510(k) K200474 ยท KPS System, Tomography, Computed, Emission
Symbia 6.7
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Mar 20, 2020 |
| Received | Feb 26, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200474
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2022 | Siemens Medical Solutions USA, Inc. Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems Terminated |
KPS | None listed |
| Aug 14, 2020 | Siemens Medical Solutions USA, Inc. Symbia S-Series and Symbia T-Series - Product Usage:
Intended use of the device SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: plana Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.