510(k) K141971 ยท KPS System, Tomography, Computed, Emission
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Sep 12, 2014 |
| Received | Jul 21, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K141971
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2017 | Siemens Medical Solutions USA Inc. Biograph 6 TruePoint, Material Number 10097289
The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to:
Image and measure the distribution of in Terminated |
KPS | None listed |
| Feb 28, 2017 | Siemens Medical Solutions USA Inc. Biograph 6 TruePoint, Material Number 10097290
The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to:
Image and measure the distribution of in Terminated |
KPS | None listed |
| Feb 28, 2017 | Siemens Medical Solutions USA Inc. Biograph 16 TruePoint - 3R, Material Number 10249555
The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to:
Image and measure the distribution Terminated |
KPS | None listed |
| Feb 28, 2017 | Siemens Medical Solutions USA Inc. Biograph 16 TruePoint TrueV - 4R, Material Number 10249556
The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to:
Image and measure the distri Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-X 4R, MATERIAL NUMBER 10248670
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registratio Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph 16 TruePoint TV, Material Number 10249556
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 40 - 3 Ring, Material Number 10097233
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registrat Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 40 TruePoint, Material Number 10097303
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provi Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provid Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 6 TruePoint, Material Number 10097289
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registra Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 64 - 3 Ring, Material Number 08727450
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registra Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regi Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that prov Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provi Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that p Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide r Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide re Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide reg Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide regis Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph mCT-X 3R, MATERIAL NUMBER 10248673
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registratio Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that pro Terminated |
KPS | None listed |
| Jun 21, 2016 | Siemens Medical Solutions USA Inc. Biograph 16 TruePoint, MATERIAL NUMBER 10249555
The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registr Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.