510(k) K052855 ยท JAK System, X-Ray, Tomography, Computed
STARSPEED SERIES CT SCANNER SYSTEMS
| Applicant | GE Healthcare, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 28, 2005 |
| Received | Oct 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 4, 2024 | GE Healthcare (China) Co., Ltd. GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA:
EU: Operator Console (for BrightSpeed,
Elite/BrightSpeed Elite Select),
Non-EU: BrightSpeed Elite, BrightSpeed
Elite Open, Classified |
JAK | None listed |
| May 24, 2018 | GE Healthcare, LLC CT Goldseal BrightSpeed 16 PWR TIO 2 YR Terminated |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare BrightSpeed X-ray system Terminated |
JAK | None listed |
| Nov 15, 2010 | GE Healthcare, LLC 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 Terminated |
JAK | None listed |
| Nov 15, 2010 | GE Healthcare, LLC GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes i Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.