Device Recall GE PET/CT System

  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927 00001010424YM8 0910212127 00001010461YM0 0910212129 00001010461YM0 0910212129 00001010471YM9 0910213084 00000980093YM9 0910212119 00000980093YM9 0910212119 00000994084YM2 0910212123X 00000984698YM1 0910213080 00001010387YM7 0910215023 00001010475YM0 0910215025 00001001897YM6 AH5703CT01 00000980120YM0 AH4001PE01 00000988410YM7 110002CT02 00000953828YM1 110017CT01 00000980106YM9 110040CT03 00000953853YM9 110059CT01 00000988410YM7 110002CT02 00000980111YM9 030355CT03 00000980111YM9 030355CT03 00001002103YM8 2858149 00000383739CN0 CT383739CN0 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00001002107YM9 082421120191 00000364134CN7 082445160009 00000365398CN7 082445040002 00000363607CN3 082421100316 00001002106YM1 082421110048 00000953856YM2 082421120171 00001001852YM1 082421120187 00001010423YM0 082421100294 00001010444YM6 082421100301 00000941008YM5 082421020154 00000988393YM5 082421030172 00000996079YM0 082421030175 00000988398YM4 082421050047 00000996082YM4 082421100157 00000984688YM2 082421100270 00000988395YM0 082421100276 00000988397YM6 082421100278 00000984685YM8 082421100283 00001010426YM3 082421160169 00001010436YM2 082421160176 00000980095YM4 082421180052 00001010457YM8 082421180061 00001023062YM1 082421180064 00000984699YM9 082421010160 00000941008YM5 082421020154 00000994089YM1 082421100284 00001002104YM6 082421120188 00000984700YM5 082421130071 00000988386YM9 082421130073 00001010451YM1 082421100307 00001010455YM2 082421290042 00001010478YM4 EE1020CT01 00001010478YM4 EE1020CT01 00000953833YM1 FI1052CT02 00000994076YM8 A9885025 00000994074YM3 C2195260 00000994074YM3 C2195260 00000994076YM8 A9885025 00000994086YM7 GOLD010094 00000363551CN3 X265413001 00000988394YM3 M1612804 00000984701YM3 M2311502 00000994086YM7 GOLD010094 00001023052YM2 M4162509 00000953834YM9 M4189251 00000953830YM7 M4217029 00000953837YM2 M4400629 00001001899YM2 M4480007 00000980112YM7 M4490502 00000980094YM7 M4505261 00000997212YM6 M4854012 00001001883YM6 M6065310 00000994076YM8 A9885025 00000941016YM8 X100719101 00001023052YM2 M4162509 00000363551CN3 X265413001 00000365551CN3 X265413001 00001023056YM3 X706835004 00000363551CN3 X265413001 00000363551CN3 X265413001 00000984701YM3 M2311502 00000988394YM3 M1612804 00000997212YM6 M4854012 00001001883YM6 M6065310 00000994074YM3 C2195260 00000984701YM3 M2311502 00000997212YM6 M4854012 00001023052YM2 M4162509 00001001883YM6 M6065310 00000980117YM6 GOLD010585 00000980117YM6 GOLD010585 00001001860YM4 420127CT01 00001010403YM2 439532CT01 00001023050YM6 442365CT01 00000980113YM5 PROS01CT04 00001023051YM4 UHAN01CT07 00000980113YM5 PROS01CT04 00000980113YM5 PROS01CT04 00000988408YM1 393115CT01 00000953843YM0 408749CT01 UNK2378661-305 439532CT01 UNK23786610001 CC4821CT03 00000941024YM2 HC1649CT01 00000953843YM0 408749CT01 00000988384YM4 HC4912CT01 00000988382YM8 HC4912CT02 00000953855YM4 HC7946CT03 UNK23786610000 HC7946CT03 UNK2378661-305 439532CT01 00000988382YM8 HC4912CT02 00001001866YM1 PC0075CT05 00000988385YM1 PC0815CT05 UNK2378661-300 PC4176CT02 00000941022YM6 PSTU02CT06 00000953843YM0 408749CT01 00000980105YM1 UC1923CT05 00000941024YM2 HC1649CT01 00000980105YM1 UC1923CT05 00000941022YM6 PSTU02CT06 00000953855YM4 HC7946CT03 00000988384YM4 HC4912CT01 00001001878YM6 00257CTS04 00000953843YM0 408749CT01 00000953843YM0 408749CT01 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001888YM5 H10632CT08 00001001886YM9 H2094CT11 00001023049YM8 H2112CT02 00000984691YM6 H5826CT01 00001010448YM7 0828210052 00001023047YM2 HU1114CT01 00000988402YM4 083021061102211 00001010441YM2 083021602200264 00000408732CN6 0002777955 00000408732CN6 0002777955 00000341516CN3 IL1020NM31 00000980121YM8 IL1082CT02 00000341516CN3 IL1020NM31 00000341516CT3 IL1082CT03 00001001875YM2 A5348207 00000994075YM0 A5258505 00000941013YM5 A257527001 UNK2378661-302 A5111130 00001010481YM8 A5118059 00000996077YM4 A5124913 00001001869YM5 A5128405 00000364957CN1 A5129956 00001001869YM5 A5128405 00001010476YM8 A5311007 00001023057YM1 A5379305 00001010440YM4 A5387105 00001001874YM5 A5618325 00001010473YM5 D5249901 00000953846YM3 A224857323 00000980115YM0 A5110016 UNK2378661-303 A5127399 00000984684YM1 A5131848 00000941018YM4 A5144908 00000953852YM1 A5164340 00000980115YM0 A5110016 00000364182CN6 A5215931 00000984692YM4 A5358103 00000988388YM5 A5361302 00000980116YM8 A5413819 00000980115YM0 A5110016 UNK2378661-304 B5343102 00000980114YM3 H5382003 00000941036YM6 QT3029 00000941014YM3 QT3030 00000941031YM7 QT3031 00000941033YM3 QT3032 00000953829YM9 QT3033 00000953850YM5 QT3034 00000953847YM1 QT3036 00000980100YM2 QT3037 00000980098YM8 QT3039 00000980096YM2 QT4049 00000980101YM0 QT4050 00000994079YM2 QT4051 00001001854YM7 QT4056 00001001855YM4 QT4057 00001010392YM7 QT4061 00000996072YM5 QT4062 00001010401YM6 QT4063 00001023043YM1 QT4065 00001023042YM3 QT4066 00001010416YM4 QT4077 00000953831YM5 QW3056 00000953849YM7 QW3057 00000980097YM0 QW3059 00000988399YM2 QW3064 00001001857YM0 QW3068 00001023044YM9 QW4087 00000953849YM7 QW3057 0000000G16ME01 QX0044 00000953827YM3 QY0012 00000980099YM6 QZ0001 00000941032YM5 QZ0021 00001023046YM4 SG0090 00000941035YM8 XF0010 00000941010YM1 XF0018 00000941025YM9 QT3027 00000941030YM9 QT3028 00000953832YM3 QT3035 00001023058YM9 QT3035 00000980103YM6 QT3040 00000980102YM8 QT3041 00000980107YM7 QT3042 00000941034YM1 QT3044 00000984686YM6 QT3045 00000984697YM3 QT3047 00000988400YM8 QT3048 00000996076YM6 QT4052 00000980110YM1 QT4054 00001001856YM2 QT4055 00001001895YM0 QT4058 00000988389YM3 QT4060 00001010452YM9 QT4064 00001023045YM6 QT4074 00001010449YM5 QV0030 00000941026YM7 QW3051 00000941028YM3 QW3060 00000941020YM0 QW3077 00000941023YM4 QW3078 00000988392YM7 QW3080 00001010453YM7 QW4088 00000988409YM9 QY0014 00000996073YM3 QY0041 00000980119YM2 QZ0020 00000941012YM7 XF0022 00000988404YM0 XF0149 00001010437YM0 0850210570 00001010439YM6 0850210572 00000984687YM4 0850210560 00000994072YM7 0850210562 00000941017YM6 KW1042CT01 00001023064YM7 KW1008CT03 00000941027YM5 KW1013CT01 00000941017YM6 KW1042CT01 00000941017YM6 KW1042CT01 00001010472YM7 LB1160CT01 00001010472YM7 LB1160CT01 00001010472YM7 LB1160CT01 00000953854YM7 LY1018CT01 00001010454YM5 0834210024 00001010454YM5 0834210024 00000354679KN3 314LS2543020 00001001867YM9 449CT2893654 00000361838CN6 44LS2551149 00000365448CN0 57CTLS16 00000953851YM3 MA1013CT02 UNK2378661-301 DVT0122 00001010463YM6 0920219033 00000361714CN9 0843210103 00001010432YM1 PL1019CT02 00001001885YM1 PL1235CT03 00001001885YM1 PL1235CT03 00001010460YM2 RU1078CT02 00001023060YM5 RU2526CT01 00001001898YM4 RU2705CT01 00000994077YM6 RU1158CT01 00001023065YM4 SA1387CT01 00000984683YM3 0847210020 00001001893YM5 ZA1071CT01 00000994088YM3 ZA1127CT02 00000994088YM3 ZA1127CT02 00001010442YM0 ZA2051CT01 00001023048YM0 ZA2244CT01 00001001891YM9 EPI28404 00000996081YM6 FPA99409 00001010462YM8 YP308712 00001010419YM8 082421140154 00001001858YM8 MPX30218 00001010446YM1 C003CT01 00001023063YM9 L006CT01 00000984694YM0 475230CT04 00000988396YM8 529170CT05 00000988396YM8 529170CT05 00000988396YM8 529170CT05 00000994078YM4 0853210154 00001010465YM1 01017CTS01 00001001892YM7 06013CTS01 00000953842YM2 38006CTS01 00001010406YM5 UK1085CT01 00000988387YM7 AE1021CT02 00001001878YM6 00257CTS04 00000980109YM3 00416CTS03 00000941019YM2 00432CTS03 00000953844YM8 00468CTS01 00000984693YM2 00664CTS02 00001001873YM7 01211CTS02 00001001872YM9 70365CTS03 00001001887YM7 00094CTS01 00000953835YM6 10470CTS01 00000953845YM5 10476CTS01 00000953848YM9 10479CTS01 00000988403YM2 10486CTS01 00001001896YM8 77266CTS02 00001001896YM8 77266CTS02 00000953841YM4 00314CTS02 00001010390YM1 941747LS16 00001010390YM1 941747LS16 00001010474YM3 928669CT 00001001861YM2 770638LS16 00001001861YM2 770638LS16 00000344959CN2 ZWL0470
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed 16 (MDAS only || , , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00001035638YM4 082421010179 00000001887YC9 082421010327 00001035639YM2 082421020108 00001035636YM8 082421020109 00001031633YM9 082421030253 00001031634YM7 082421030254 00000003852YC1 082421030266 00001031640YM4 082421040157 00001035634YM3 082421060051 00000001885YC3 082421060054 00001035641YM8 082421080078 00001031632YM1 082421090164 00001035640YM0 082421090168 00001031639YM6 082421100318 00001031638YM8 082421120200 00000003853YC9 082421140187 00001031637YM0 082421150068 00000001883YC8 082421200244 00000001888YC7 082421270069 00001035633YM5 082421310091 00000001891YC1 082421040171 00000001892YC9 082421040177 00000001889YC5 082421090174 00000001890YC3 082421090175 00000001886YC1 082421310106
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed Ultra (8-slice MDAS), 5120327-3 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000002631PT0 4860AW442 00000002631PT0 4860AW442 00000318118CN7 0910213115 00000002808PT4 0910453003P 00000318118CN7 0910213115 00000318118CN7 0910213115 00000980093YM9 0910212119 00000002247PT5 090016PT01 00000326200CN3 110012CT01 00000311426CN1 030018CT01 00000002103PT0 2728449 00000003306PT8 2757760XXX 00000003306PT8 2757760XXX 00000003310PT0 47867 00000002103PT0 2728449 00000002103PT0 2728449 00000339630CN6 BG4029CT01 00000298328CN6 204787LS1 00000298660CN2 204787LSPD2 00000307018CN2 416249LS16 00000309304CN4 519744LS16 00000309524CN7 819379LS 00000310680CN4 418862LS 00000312264CN5 450656LS 00000316257CN5 613761LS16 00000317195CN6 604988LS16 00000318444CN7 514499LS 00000318927CN1 514468BLS 00000319310CN9 519421LS16 00000324459CN7 450466LS 00000328940CN2 450654LS 00000329994CN8 819561LS 00000332076CN9 506648LS16 00000335314CN1 514934CLS16 00000341799CN5 416284LS16 00000341801CN9 416744LS16 00000341802CN7 905883LS16 00000347191CN9 450778LS 00000348810CN3 416924DST 00000349405CN1 514934BDST 00000994091YM7 418549LS 00000334561CN8 26329CT4X 00000002642PT7 082445310001 00000002660PT9 082445310003 00000340577CN6 082421120176 00000340630CN3 082421140148 00000989604YM4 082421030247 00000989603YM6 082421040128 00000989606YM9 082421080068 00000989606YM9 082421080068 00000989602YM8 082421100277 00000989607YM7 082421210116 00000352887CN4 USONCDST16 00000346880CN8 2532905LIG16 00000295643CN1 FI1017CT02 00000334897CN6 A9190135 00000001843PT2 B4155412 00000334897CN6 A9190135 00000002494PT3 GOLD010013 00000341585CN8 GOLD010316 00000336468CN4 M4143946 00000002494PT3 GOLD010013 00000339849CN2 M4215541 00000339849CN2 M4215541 00000336833CN9 M4434860 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000001843PT2 B4155412 00000293499CN0 M5481223 00000302751CN3 M4516011 00000309305CN1 M4491923 00000310268CN8 M4191025 00000313650CN4 C6010809 00000326112CN0 M1279722 00000329304CN0 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310BHDST 00000365402CN7 732360DST 00000365431CN6 856778DISCST 00000365447CN2 RADNETPT1808 00000366279CN8 760633CT2 00000366341CN6 615884CT1 00000366432CN3 253944CT16 00000366433CN1 417820LSER 00000367476CN9 501922HVCT 00000367929CN7 270926LS16 345974CN0 SHICT69 953828YM1 SHICT19 997216YM7 972549HP60 984695YM7 515247CT5 941025YM9 706922CT 00000404615CN7 806775PETCT 00000941009YM3 713MHDSTM 00000953839YM8 305592LS16 00000953840YM6 406266BHCT1 00000980118YM4 INSIGHTPCT1331 00000984682YM5 615435PCT 00000984689YM0 9167345X 00000984695YM7 515247CT5 00000984696YM5 901726CT2 00000988390YM1 864225CT 00000988401YM6 925933CT3 00000988405YM7 303662CT16 00000988406YM5 440293LS16 00000994073YM5 423622CT 00000994080YM0 407321CFC2 00000994081YM8 901226CT5 00000994082YM6 206386ERCT 00000994085YM9 318442LS16 00000994090YM9 620343CT 00000997213YM4 610325LS16 00000997215YM9 NELCTLS16 00000997220YM9 RADNETCT1401 00001002102YM0 816691PCT16 00001002105YM3 530UCVETCT 00001002108YM7 ALLIANCECT148 00000002993PT4 38852995PETMET
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    Discovery LS, 2286327 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000294153CN2 0910212097 00000309306CN9 0910212101 00000309960CN3 0910212104 00000309960CN3 0910212104 00000311052CN5 0910212105 00000321402CN0 0910212106 00000321402CN0 0910212106 00000337340CN4 0910212115 00000337340CN4 0910212115 00000337340CN4 0910212115 00000297003CN6 0910213064 00000313645CN4 0910213070 00000301209CN3 0910215018 00000313097CN8 0910216036 00000337344CN6 0910216041 00000297460CN8 AH1410CT06 00000325191CN5 AH5362CT02 00000310728CN1 110037CT01 00000310728CN1 110037CT01 00000299935CN7 190020CT03 00000311058CN2 190052CT06 00000297386CN5 190059CT04 00000311058CN2 190052CT06 00000311426CN1 030018CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000327271CN3 10026 00000346702CN4 1350651 00000310682CN0 2850998 00000310682CN0 2850998 00000327815CN7 CT327815CN7 00000332075CN1 BG4037CT01 UNK23399850000 BG4037CT01 00000316663CN4 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    Discovery ST, , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000002493PT5 0850450029
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed Plus (4-slice MDAS || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000006841PT1 PET368725CN8 00000004411PT5 4512-1 00000004411PT5 4512-1 00000006841PT1 PET368725CN8 00000005376PT9 PET357769CN9 00000005670PT5 082426140014 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006119PT2 082445030003 00000005815PT6 082445050003 00000006146PT5 082445090002 00000005808PT1 082445100008 00000006177PT0 082445100009 00000006175PT4 082445130004 00000005670PT5 082426140014 00000005808PT1 082445100008 00000006500PT3 082445160007 00000006242PT2 082445190002 00000006200PT0 082445250002 00000005251PT4 H4858964 00000005121PT9 M4143813 00000005352PT0 M4144860 00000005323PT1 X105967801 00000006194PT5 HU1167PT01 00000006762PT9 0004168403 00000006762PT9 0004168403 00000005809PT9 IE1005PT01 00000004588PT0 IL1062NM18 00000006120PT0 A5107746 UNK51012720002 A5107746 UNK51012720001 A5215931 00000006003PT8 A5333025 00000004619PT3 A99263301 00000006292PT7 YD0024 00000006293PT5 YD0025 00000006039PT2 YE0001 00000006273PT7 YE0002 00000006272PT9 YE0003 00000006345PT3 YE0004 00000006346PT1 YE0005 00000006808PT0 YE0006 00000006488PT1 YE0007 00000006403PT0 YE0008 00000006368PT5 YE0011 00000006274PT5 YE0077 00000005920PT4 YE0101 00000006141PT6 YE0102 00000006076PT4 YE0103 00000006404PT8 YE0104 00000006496PT4 YE0105 00000006405PT5 YE0106 00000006453PT5 YE0107 00000006636PT5 YE0108 00000006331PT3 YE0110 00000006347PT9 YE0111 00000006454PT3 YE0112 00000006115PT0 YE0201 00000006407PT1 YE0202 00000006611PT8 YE0203 00000006245PT5 YE0205 00000006810PT6 YE0210 00000006843PT7 YE0211 00000005813PT1 YE0214 00000006367PT7 YE0109 00000006304PT0 YE0204 00000005813PT1 YE0214 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004463PT6 0850450055 00000005495PT7 0850450056X1 00000005342PT1 0850450057 00000005342PT1 0850450057 00000005878PT4 0850450058 00000006176PT2 0850450059 00000006176PT2 0850450059 00000005785PT1 0834450001 00000005785PT1 0834450001 00000005719PT0 2535997DST 00000005719PT0 2535997DST 00000006486PT5 2546945DST 00000006148PT1 FE816135 UNK51012720004 FE816135 00000004732PT4 FEG81300 00000006302PT4 NP739714 UNK51012720000 Not Available 00000006201PT8 C001PE03 00000006201PT8 C001PE03 00000006294PT3 259130PE01 00000006294PT3 259130PE01 00000005184PT7 0853450020 00000004676PT3 0853450021 00000005784PT4 0853450023 00000005880PT0 0853450026 00000006244PT8 0853450038 00000006244PT8 0853450038 00000006501PT1 0853450062 00000004624PT3 06008PET01 00000005169PT8 01293DST01 UNK51012720003 10495DST01 00000005892PT5 561883DST 00000006457PT6 388559737PETMET
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Description du dispositif
    LightSpeed QX/I (4-slice MDAS) || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer