510(k) K152880 ยท KPS System, Tomography, Computed, Emission
Biograph Horizon PET/CT
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Jan 12, 2016 |
| Received | Sep 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2018 | Siemens Medical Solutions USA, Inc. Siemens Biograph Horizon PET/CT System,
Product Usage:
The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.