510(k) K231833 ยท KPS System, Tomography, Computed, Emission
Biograph Vision.X and Biograph Vision.X Edge
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Jul 13, 2023 |
| Received | Jun 22, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231833
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.