AlignRT

  • Modèle / numéro de série
    Affected software version:  Software versions 5.0.1738 and 5.0.1742 only.  Affected serial numbers:  248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
  • Description du dispositif
    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Vision Rt Inc, 8840 Stanford Blvd, Columbia MD 21045-5827
  • Source
    USFDA

17 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Serial numbers (internally referred to as PCR numbers):   USA: 247-018, 247-039, 247-040, 247-053, 247-060, 247-061 , 247-062, 247-063, 247-068, 247-071 , 247-075, 247-076 , 247-078, 247-081, 247-083, 247-096, 247-099, 247-100,, 247-101, 247-102 , 247-110 , 247-118, 247-119, 247-122, 247-124, 247-127, 247-129, 247-130, 247-138, 247-140, 247-142, 247-149, 247-150, 247-153, 247-161, 247-167, 247-171, 247-184, 247-194, 247-200, 247-207, 247-212, 247-213, 248-012, 248-018, 248-041  Rest of the world:  247-035, 247-073, 247-114, 247-131, 247-147, 247-148, 247-188
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
  • Manufacturer
  • Modèle / numéro de série
    TrueBeam version 2.0/2.5 with any version OSMS.  AlignRT Serial Numbers: 247-0200 247-0209 248-0013 248-0057 248-0070 249-0057 249-0066 249-0163 249-0164 249-0195 249-0226 249-0274 249-0050 249-0286 249-0277 248-0044 249-0227 247-0208 249-0047 247-0218 248-0050 248-0043 248-0048 249-0293 249-0155.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom.
  • Description du dispositif
    Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; || Radiology: The AlignRT Plus system is indicated for use to position || and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.
  • Manufacturer
  • Modèle / numéro de série
    Serial Number of the device(s) distributed 248-016 248-021 248-022 248-030 248-038 248-041 248-063 248-064 249-1514 249-1516 248-071 249-0239 248-073 248-080 248-084 249-0043 249-0055 249-0056 249-0058 249-0069 249-0130 249-0137 249-1509 249-0141 249-0275 249-0152 249-0162 249-0169 249-0251 249-0253 249-0254 249-0288 249-1503 249-1512 249-1518 249-TBD 249-0061 249-0131 249-0256 249-0289 249-0290 249-TBD 248-083 249-0273 249-0276 249-1500 249-1519
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.
  • Description du dispositif
    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Radiotherapy / Radiation protection - radiotherapy treatment planning systems
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Radiotherapy / Radiation protection - radiotherapy treatment planning systems
  • Manufacturer
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