510(k) K170904 ยท KPS System, Tomography, Computed, Emission
Biograph Horizon PET/CT
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Jun 1, 2017 |
| Received | Mar 28, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170904
| 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 |
| Sep 28, 2018 | Siemens Medical Solutions USA, Inc. Biograph Horizon
a) 3R, Material Number 10532746
b) 4R, Material Number 10532748
The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emissio Terminated |
KPS | None listed |
| Feb 21, 2018 | Siemens Medical Solutions USA, Inc. Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information. Terminated |
KPS | None listed |
| Jan 26, 2018 | Siemens Medical Solutions USA, Inc. Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.