510(k) K041955 ยท KPS System, Tomography, Computed, Emission
GEMINI PET/CT IMAGING SYSTEM
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 29, 2004 |
| Received | Jul 21, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041955
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.