510(k) K171681 ยท KPS System, Tomography, Computed, Emission
Hermes Medical Imaging Suite v5.7
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Nov 21, 2017 |
| Received | Jun 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171681
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2024 | Hermes Medical Solutions AB Hybrid Recon software on Hermes Medical Imaging Suite version 6.1
Hybrid Recon software versions affected are 4.0.0x and 5.0.0 Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.