510(k) K042935 ยท KPS System, Tomography, Computed, Emission
GEMINI GXL
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 9, 2004 |
| Received | Oct 25, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042935
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2007 | Philips Medical Systems (Cleveland) Inc Nuclear medicine systems:
Gemini 16, Model 4535 679 28961.
Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691.
Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and Terminated |
KPS | None listed |
| Oct 21, 2005 | Philips Medical Systems (Cleveland) Inc Gemini GXL PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679 75691. Catalog numbers: 16 slice Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.