Devices

GE LightSpeed VCT

  • Model / Serial
    Model 5212920-300, serial numbers: 00000021775YC2. 00000408285CN5. 00000409136CN9. 00000412029CN1. 00000412391CN5. 00000414803CN7. 00000415599CN0. 00000416813CN4. 00000417885CN1.   Model 5212920-310, serial numbers: 00000416740CN9. 00000417311CN8. 00000417519CN6. 00000417884CN4. 00000417886CN9. 00000417916CN4. 00000417917CN2. 00000417918CN0. 00000417919CN8. 00000417925CN5. 00000417926CN3. 00000417989CN1. 00000417990CN9. 00000418000CN6. 00000418055CN0. 00000418056CN8. 00000418057CN6. 00000418058CN4. 00000418059CN2. 00000418060CN0. 00000418062CN6. 00000418063CN4. 00000418064CN2. 00000418065CN9. 00000418126CN9. 00000418141CN8. 00000418142CN6. 00000418179CN8. 00000418218CN4. 00000418219CN2. 00000418220CN0. 00000418221CN8. 00000418222CN6. 00000418246CN5. 00000418260CN6. 00000418261CN4. 00000418266CN3. 00000418272CN1. 00000418293CN7. 00000418296CN0. 00000418337CN2. 00000418355CN4. 00000418365CN3. 00000418400CN8. 00000418404CN0. 00000418467CN7. 00000418541CN9. 00000418542CN7. 00000418581CN5. 00000418586CN4. 00000418604CN5. 00000418706CN8. 00000418717CN5. 00000418789CN4. 00000418790CN2. 00000418793CN6.   Model 5311595-10, serial numbers: 00000031546CO5. 00000031835CO2. 00000031838CO6.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
  • Product Description
    GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. || Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
  • Manufacturer
    GE Healthcare, LLC
  • 1 Event

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

One device with a similar name

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Device Recall GE LightSpeed VCT System
  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Guam, Hong Kong, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia , Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain , Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, Vietnam, and Yugoslavia.
  • Product Description
    The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
  • Manufacturer
    GE Healthcare