510(k) K151486 ยท KPS System, Tomography, Computed, Emission
Biograph mCT and mCT Flow PET/CT Scanners
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Jul 17, 2015 |
| Received | Jun 2, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151486
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT S(40)-3R, Material Number 10248668
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT S(64)-3R, Material Number 10248669
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT X-4R, Material Number 10248670
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that pro Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT S(40)-4R, Material Number 10248671
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT S(64)-4R, Material Number 10248672
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT X-3R, Material Number 10248673
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that pro Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanne Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scan Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT 20 Excel, Material Number 10507786
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT Flow Edge-4R, Material Number 10528955
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners Terminated |
KPS | None listed |
| Jan 10, 2017 | Siemens Medical Solutions USA Inc. Biograph mCT Flow 40-4R, Material Number 10529159
The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners th Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.