510(k) K003437 ยท LLZ System, Image Processing, Radiological
ODYSSEY LX, MODEL 211320
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 2, 2001 |
| Received | Nov 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2003 | Philips Medical Systems (Cleveland) Inc Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.