510(k) K123737 ยท KPS System, Tomography, Computed, Emission
BIOGRAPH MCT FAMILY
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Jan 29, 2013 |
| Received | Dec 5, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123737
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786
Product Usage:
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov Terminated |
KPS | None listed |
| Jun 15, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672
Product Usage:
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provid Terminated |
KPS | None listed |
| Jun 15, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956
Product Usage:
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov Terminated |
KPS | None listed |
| Jun 15, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958
Product Usage:
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT S(40)-4R, Model Number 10248671 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT S(64)-4R, Model Number 10248672 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT X-4R, Model Number 10248670 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph mCT Flow Edge-4R, Model Number 10528955 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 Terminated |
KPS | None listed |
| Aug 5, 2015 | Siemens Medical Solutions USA Inc. Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 Terminated |
KPS | None listed |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT Flow Edge-4R, System Material Number 10528955.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide r Terminated |
KPS | None listed |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT Flow 40-4R, System Material Number 10529159.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg Terminated |
KPS | None listed |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT X-4R, System Material Number 10248670.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat Terminated |
KPS | None listed |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT S(64)-4R, System Material Number 10248672.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Dec 16, 2014 | Siemens Medical Solutions USA Inc. Biograph mCT S(40)-4R, System Material Number 10248671.
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.