510(k) K882312 ยท IYX Camera, Scintillation (Gamma)
MODEL 3000 NUCLEAR CAMERA
| Applicant | Ohio Imaging, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 14, 1988 |
| Received | Jun 3, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 21, 2003 | Philips Medical Systems Inc Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335. Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.