510(k) K884674 ยท IYX Camera, Scintillation (Gamma)
APEX 415 ANGER CAMERA
| Applicant | Elscint, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Apr 17, 1989 |
| Received | Nov 8, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.