510(k) K032036 ยท KPS System, Tomography, Computed, Emission
GEMINI 16
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 11, 2003 |
| Received | Jul 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032036
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Terminated |
JAK | None listed |
| Aug 30, 2005 | Philips Medical Systems (Cleveland) Inc Gemini 16 PET/CT sytem, Slice Configuration Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.