510(k) K002553 ยท KPS System, Tomography, Computed, Emission
DS DS I-SERIES
| Applicant | Smv America, Twinsburg OH, US |
| Decision | Substantially Equivalent, Sep 15, 2000 |
| Received | Aug 17, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002553
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2026 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING SMV DSI,
System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.