510(k) · Cleared
Recalled · Class II · 2016Biograph mCT and mCT Flow PET/CT Scanners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Jul 17, 2015 as substantially equivalent to K123737 (Siemens Medical Solutions USA, Inc., 2013) after a 45-day review. Its family tree reaches back 12 generations to 2000. 34 later devices descend from it. It has been recalled 11 times.
- Decided
- Jul 17, 2015
- Review
- 45 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 12 generations to K002715 (2000). 18 ancestors in all, the oldest K843696 (1985). 34 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 2 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 1 generation backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- This deviceK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 16 of its ownK172143 uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · Recalled
- Descendant · cites it directly · 9 of its ownK173578 Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK180811 Biograph VisionSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 3 generations on · 7 of its ownK190900 Biograph VisionSiemens Medical Solutions USA, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK193248 Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc. · 2020 · Recalled
Show all 12 generations
- Root · 12 generations backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- 11 generations backK013504 Modification to: Ecat Lso Pet/CT ScannerCti Pet Systems, Inc. · 2001 · Recalled
- 10 generations backK023518 Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002 · Recalled
- 9 generations backK033431 Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 2003 · Recalled
- 8 generations backK042467 Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 2004 · Recalled
- 7 generations backK050509 Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
- 6 generations backK060060 Biograph 6Siemens Medical Solutions USA, Inc. · 2006
- 5 generations backK060631 Biograph 64 and Biograph 40Siemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK081453 Biograph HD FamilySiemens Medical Solutions USA, Inc. · 2008
- 3 generations backK101550 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2010
- 2 generations backK113448 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2011
- 1 generation backK123737 Biograph MCT FamilySiemens Medical Solutions USA, Inc. · 2013 · Recalled
- This deviceK151486 Biograph mCT and mCT Flow PET/CT ScannersSiemens Medical Solutions USA, Inc. · 2015
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K172143uMI 780 PET/CT SystemShanghai United Imaging Healthcare Co., Ltd. · 2018 · cites it directly16descendants
- K173578Biograph mCT Family of PET/CT SystemsSiemens Medical Solutions USA, Inc. · 2017 · cites it directly9descendants
- K180811Biograph VisionSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on8descendants
- K190900Biograph VisionSiemens Medical Solutions USA, Inc. · 2019 · 3 generations on7descendants
- K193248Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| −11 | K013504 | Modification to: Ecat Lso Pet/CT Scanner | Cti Pet Systems, Inc. | 2001 | 2 |
| −10 | K023518 | Ecat Lso Pet/CT 16 | Cti Pet Systems, Inc. | 2002 | 1 |
| −9 | K033431 | Lso Pet/CT Hirez and Lso Pet/CT 16 Hirez | Cti Pet Systems, Inc. | 2003 | 1 |
| −8 | K042467 | Lso Pet/CT Hirez 64 | Cti Pet Systems, Inc. | 2004 | 1 |
| −7 | K050509 | Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I | Cti Pet Systems, Inc. | 2005 | — |
| −6 | K060060 | Biograph 6 | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −5 | K060631 | Biograph 64 and Biograph 40 | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −4 | K081453 | Biograph HD Family | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −3 | K101550 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2010 | — |
| −2 | K113448 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2011 | — |
| −1 | K123737 | Biograph MCT Family | Siemens Medical Solutions USA, Inc. | 2013 | 17 |
| 0 (this device) | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K172143 | uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | 2 |
| +1 | K173578 | Biograph mCT Family of PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2017 | 2 |
| +2 | K180811 | Biograph Vision | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +3 | K190900 | Biograph Vision | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +2 | K193248 | Biograph Vision, Biograph mCT Family of PET/CTs | Siemens Medical Solutions USA, Inc. | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123737 | Biograph MCT FamilySummary page 5…iemens Medical Solutions USA, Inc. Product Code: 90 KPS and 90 JAK Device Class: Class II 510(k) Number: K123737 Reference Devices: Device Name: Somatom Definition AS/AS+ Somatom Defi… | 2013 |
| † | K143400 | SOMATOM Definition AS/AS+ | 2015 |
| † | K143401 | SOMATOM Definition Edge | 2015 |
What descends from it? (34)
See all 344 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2016 | Class II | Z-0993-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0995-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-1002-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0992-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0994-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0996-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0997-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-1000-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-1001-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0998-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
| Dec 13, 2016 | Class II | Z-0999-2017 | Device Design | Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- 9 of the 18 ancestors have a recall of any class.
- Of its descendants, K172143 (Shanghai United Imaging Healthcare Co., Ltd., 2018) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K123737.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem…
Read the full statement (206 words)
The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission
Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data
from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem
images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various
metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction
maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET
diagnostic imaging.
These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing,
diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151486: Biograph mCT and mCT Flow PET/CT Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151486
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026