510(k) K082761 ยท JAK System, X-Ray, Tomography, Computed
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 8, 2008 |
| Received | Sep 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2017 | GE Healthcare, LLC GE Healthcare LightSpeed VCT 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.