510(k) K193178 ยท KPS System, Tomography, Computed, Emission
Biograph Horizon
| Applicant | Siemens Medical Solution USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Feb 12, 2020 |
| Received | Nov 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2023 | Siemens Medical Solutions USA, Inc. SIEMENS Biograph Horizon 3R Mobile; 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.