510(k) K212604 ยท KPS System, Tomography, Computed, Emission
Symbia VA10A Family
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Sep 16, 2021 |
| Received | Aug 17, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2023 | Siemens Medical Solutions USA, Inc. The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly:
(a) Symbia Pro.specta Q3, Model 11364751;
(b) Symbia Pro.specta X Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.