510(k) K952674 ยท KPS System, Tomography, Computed, Emission
TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Sep 26, 1995 |
| Received | Jun 12, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952674
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING Elscint Cardial; 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.