510(k) K922080 ยท KPS System, Tomography, Computed, Emission
GENESYS II
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, Jul 17, 1992 |
| Received | May 4, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2015 | Philips Medical Systems (Cleveland) Inc Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH Terminated |
KPS | None listed |
| Apr 26, 2014 | Philips Medical Systems (Cleveland) Inc Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143.
Used to produce images depicting the anatomical distribution o Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.