510(k) K193248 ยท KPS System, Tomography, Computed, Emission
Biograph Vision, Biograph mCT Family of PET/CTs
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | Nov 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2023 | Siemens Medical Solutions USA, Inc. SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile Open, Classified |
KPS | None listed |
| Feb 13, 2023 | Siemens Medical Solutions USA, Inc. SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge Open, Classified |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.