Innova

Software Versions:  8:00, 8.01, 8.02, 8.03 or 8.04

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution (USA and Canada)

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)

serial numbers: 00000007C20041, 00000046457BU0, 00000046582BU1, 00000051324BU5, 000000MI000555, 00000454582BU8, 00000455797BU9, 00000459650BU8, 00000459651BU6, 00000459652BU4, 00000459653BU2, 00000459654BU0, 00000459655BU7, 00000459656BU5, 00000459657BU3, 00000459658BU1, 00000459659BU9, 00000459661BU5, 00000459663BU1, 00000459664BU9, 00000459665BU6, 00000459667BU2, 00000459668BU0, 00000459669BU8, 00000459670BU6, 00000459672BU2, 00000459673BU0, 00000459674BU8, 00000459675BU5, 00000459676BU3, 00000459677BU1, 00000459891BU8, 00000464564BU4, 00000464565BU1, 00000464566BU9, 00000464567BU7, 00000464568BU5, 00000464570BU1, 00000464571BU9, 00000464572BU7, 00000464573BU5, 00000464574BU3, 00000464576BU8, 00000464577BU6, 00000464578BU4, 00000464579BU2, 00000464580BU0, 00000464581BU8, 00000464582BU6, 00000464585BU9, 00000464586BU7, 00000464587BU5, 00000464588BU3, 00000464589BU1, 00000464590BU9, 00000464591BU7, 00000464592BU5, 00000464593BU3, 00000465560BU1, 00000465794BU6, 00000465795BU3, 00000465796BU1, 00000465821BU7, 00000465822BU5, 00000465823BU3, 00000465825BU8, 00000465827BU4, 00000465828BU2, 00000465829BU0, 00000465830BU8, 00000465831BU6, 00000465832BU4, 00000465834BU0, 00000465835BU7, 00000465836BU5, 00000465837BU3, 00000465838BU1, 00000465839BU9, 00000465840BU7, 00000465841BU5, 00000465842BU3, 00000465843BU1, 00000465845BU6, 00000465846BU4, 00000465848BU0, 00000465849BU8, 00000466836BU4, 00000466838BU0, 00000466839BU8, 00000466841BU4, 00000466843BU0, 00000466844BU8, 00000466845BU5, 00000466846BU3, 00000466847BU1, 00000466848BU9, 00000466849BU7, 00000466850BU5, 00000466851BU3, 00000466852BU1, 00000466853BU9, 00000466856BU2, 00000466857BU0, 00000466859BU6, 00000466860BU4, 00000466861BU2, 00000466862BU0, 00000466863BU8, 00000466864BU6, 00000466865BU3, 00000478319BU7, 00000478320BU5, 00000478323BU9, 00000478324BU7, 00000478326BU2, 00000478327BU0, 00000478328BU8, 00000478330BU4, 00000478331BU2, 00000478333BU8, 00000478337BU9, 00000478338BU7, 00000478339BU5, 00000478340BU3, 00000478341BU1, 00000478342BU9, 00000478345BU2, 00000478346BU0, 00000478347BU8, 00000478348BU6, 00000485080BU6, 00000489536BU3, 00000489537BU1, 00000489538BU9, 00000489539BU7, 00000489540BU5, 00000489542BU1, 00000489543BU9, 00000489544BU7, 00000489546BU2, 00000489547BU0, 00000489548BU8, 00000489549BU6, 00000489551BU2, 00000489553BU8, 00000489555BU3, 00000489557BU9, 00000489558BU7, 00000489561BU1, 00000489562BU9, 00000489564BU5, 00000489565BU2, 00000489683BU3, 00000489684BU1, 00000489688BU2, 00000489738BU5, 00000489744BU3, 00000489747BU6, 00000489753BU4, 00000489756BU7, 00000489757BU5, 00000489761BU7, 00000489763BU3, 00000489770BU8, 00000489772BU4, 00000498661BU8, 00000498679BU0, 00000498710BU3, 00000498711BU1, 00000498712BU9, 00000498713BU7, 00000498715BU2, 00000498717BU8, 00000498718BU6, 00000498719BU4, 00000498720BU2, 00000498721BU0, 00000498722BU8, 00000498723BU6, 00000508755BU6, 00000509439BU6, 00000512697BU4, 00000512701BU4, 00000512713BU9, 00000512715BU4, 00000512727BU9, 00000512818BU6, 00000512819BU4, 00000512821BU0, 00000512822BU8, 00000512823BU6, 00000512828BU5, 00000512868BU1, 00000512870BU7, 00000512871BU5, 00000512874BU9, 00000512875BU6, 00000512877BU2, 00000512880BU6, 00000512883BU0, 00000512888BU9, 00000512891BU3, 00000512892BU1, 00000512894BU7, 00000512898BU8, 00000513110BU7, 00000513118BU0, 00000513161BU0, 00000513190BU9, 00000513204BU8, 00000513206BU3, 00000513207BU1, 00000513208BU9, 00000513209BU7, 00000513212BU1, 00000513244BU4, 00000513265BU9, 00000513274BU1, 00000513296BU4, 00000513516BU5, 00000513533BU0, 00000513539BU7, 00000513541BU3, 00000513547BU0, 00000513555BU3, 00000513558BU7, 00000513560BU3, 00000513567BU8, 00000519094BU7, 00000519100BU2, 00000519106BU9, 00000519109BU3, 00000519121BU8, 00000519125BU9, 00000519129BU1, 00000519131BU7, 00000520045BU6, 00000520048BU0, 00000520050BU6, 00000520065BU4, 00000520070BU4, 00000520075BU3, 00000520083BU7, 00000526275BU3, 00000526389BU2, 00000526556BU6, 00000526557BU4, 00000526560BU8, 00000526562BU4, 00000526563BU2, 00000526648BU1, 00000526681BU2, 00000529461BU6, 00000530106BU4, 00000530116BU3, 00000530120BU5, 00000530242BU7, 00000530246BU8, 00000530248BU4, 00000530410BU0, 00000530413BU4, 00000536802BU2, 00000538053BU0, 00000543790BU0, 00000544289BU2, 00000545052BU3, 00000546574BU5, 00000547017BU4. systems id: 835160017, 82416070006, 00192VAS05, 214947MINNOVA2, 305682IN2X, 318448INNOVA3, 83INNOVA2588441, B5219603, H0002VAS66, HU1099VA02, RPINNOVA2100, YV0053.

Radiology Devices

2

No

within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom

GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

serial numbers: 00000007C20050, 00000061993GE2, 00000464046BU2, 00000464088BU4, 00000464127BU0, 00000477752BU0, 00000477766BU0, 00000477779BU3, 00000477793BU4, 00000477807BU2, 00000477808BU0, 00000477816BU3, 00000477827BU0, 00000477833BU8, 00000477840BU3, 00000479549BU8, 00000479577BU9, 00000485033BU5, 00000489690BU8, 00000489717BU9, 00000490496BU7, 00000491059BU2, 00000492423BU9, 00000493965BU8, 00000497494BU5, 00000498674BU1, 00000498692BU3, 00000498707BU9, 00000498882BU0, 00000498888BU7, 00000499681BU5, 00000499701BU1, 00000499702BU9, 00000499711BU0, 00000499720BU1, 00000499728BU4, 00000499936BU3, 00000505083BU6, 00000505109BU9, 00000509176BU4, 00000509205BU1, 00000509236BU6, 00000509237BU4, 00000509242BU4, 00000509243BU2, 00000509246BU5, 00000509252BU3, 00000509253BU1, 00000510040BU9, 00000511613BU2, 00000511672BU8, 00000511684BU3, 00000511685BU0, 00000511692BU6, 00000512738BU6, 00000512755BU5, 00000512825BU1, 00000512826BU9, 00000512829BU3, 00000512831BU9, 00000512834BU3, 00000512840BU0, 00000512866BU5, 00000512884BU8, 00000512889BU7, 00000512890BU5, 00000512897BU0, 00000512905BU1, 00000513093BU5, 00000513107BU3, 00000513112BU3, 00000513128BU9, 00000513172BU7, 00000513175BU0, 00000513183BU4, 00000513184BU2, 00000513189BU1, 00000513205BU5, 00000513267BU5, 00000513277BU4, 00000513278BU2, 00000513523BU1, 00000513527BU2, 00000513536BU3, 00000513544BU7, 00000513548BU8, 00000513549BU6, 00000513551BU2, 00000513570BU2, 00000513571BU0, 00000513576BU9, 00000513589BU2, 00000515118BU8, 00000518728BU1, 00000519107BU7, 00000519126BU7, 00000519153BU1, 00000520046BU4, 00000521647BU8, 00000526236BU5, 00000526308BU2, 00000526309BU0, 00000526348BU8, 00000526382BU7, 00000526383BU5, 00000526384BU3, 00000526386BU8, 00000526559BU0, 00000528646BU3, 00000529467BU3, 00000529510BU0, 00000529664BU5, 00000529681BU9, 00000530226BU0, 00000534470BU0, 00000534725BU7, 00000538734BU5, 00000538740BU2, 00000543268BU7, 00000545045BU7, 00000545590BU2, 00000546170BU2, 00000546434BU2, 00000546573BU7, 00000547027BU3, 00000547211BU3, 00000549174BU1, 00000772852-02, 00002UA6251HCZ, 00002UA6420FDN. systems id: 2667313, 82416040018, 82416130018.

Radiology Devices

2

No

within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom

GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

serial number: 00000007C20046, 00000088514VE5, 00000453906BU0, 00000453949BU0, 00000464077BU7, 00000464473BU8, 00000477785BU0, 00000477790BU0, 00000477801BU5, 00000477819BU7, 00000477822BU1, 00000477831BU2, 00000477835BU3, 00000477837BU9, 00000477841BU1, 00000479528BU2, 00000489698BU1, 00000489699BU9, 00000489768BU2, 00000496743BU6, 00000497530BU6, 00000498660BU0, 00000499684BU9, 00000499708BU6, 00000505091BU9, 00000509178BU0, 00000509203BU6, 00000509244BU0, 00000509248BU1, 00000509254BU9, 00000511620BU7, 00000511652BU0, 00000511702BU3, 00000512694BU1, 00000512706BU3, 00000512710BU5, 00000512721BU2, 00000512824BU4, 00000512830BU1, 00000512832BU7, 00000512833BU5, 00000512863BU2, 00000512865BU7, 00000512881BU4, 00000512886BU3, 00000512893BU9, 00000512896BU2, 00000512908BU5, 00000513090BU1, 00000513142BU0, 00000513174BU3, 00000513198BU2, 00000513200BU6, 00000513203BU0, 00000513218BU8, 00000513227BU9, 00000513242BU8, 00000513243BU6, 00000513540BU5, 00000513550BU4, 00000513559BU5, 00000519098BU8, 00000526307BU4, 00000526310BU8, 00000526349BU6, 00000526385BU0, 00000526537BU6, 00000526676BU2, 00000526678BU8, 00000528507BU7, 00000528634BU9, 00000529470BU7, 00000529682BU7, 00000530250BU0, 00000544202BU5, 00000545958BU1, 00002UA63008FC, 000782415-0004. systems id: 574294IN41.

Radiology Devices

2

No

within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom

GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

SYSTEM ID: 65049331 850060732 2538483100 4082593100 7133933100 9284533100 82416060004 0002728403 01224VAS04  082416040025 082416100008 082416120017 082416230005 202782LABB  214324INNOVA2 27305ANGI1 303629CL4 303788CL2 318254CL 325428CATH1 361857CATH1 361980INNOVA2  478274CTH1 479441CV1  4959INV31 503561CL3 512901NI3100 563421CATHLAB8 573AMC3100  600123VA02  619482INNOVA1  650369SV3 704355RM2  706774HT8  717270INNOVA31  727942CATH  732776CATH6 770HMCCL2  787844INNOVACL 803256LAB2  808485INNOVA  814231C1 815226INN2  864512CL1  864512CL2  865481CCL2  951788INNOVA2 A51273120 BPINNOVA4 BPINNOVA5  BY4067VA02 BY4069VA01 FPG30528  HU1042VA01  IL1098VA01 NPV15952  PL1008VA02 RU1295VA03 RU1295VA04 RU1453VA01 RU1618VA01 RU1999VA01  RU2076VA02 RU2741VA03 RU2747VA01  RU3260VA01  RU3290VA01 RU3304VA01  RU3317VA01 RU3328VA01 UA4230VA01 XF0158 YV0044 YV0171  YV0175  YV0180  YV0700 Z001RX07

Radiology Devices

2

No

Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.

GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)