510(k) K911346 ยท IYX Camera, Scintillation (Gamma)
SOPHYCAMERA DSX BODYTRAK
| Applicant | Sopha Medical Systems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Apr 18, 1991 |
| Received | Mar 27, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV BodyTrack,
System, Tomography, Computed, Emission Open, Classified |
IYX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.