# K141971: Biograph True Pet/CT Family Software

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 12, 2014 after 53 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K002715 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123737: Biograph MCT Family, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.

## Recalls of this device
- Feb 20, 2017 · Class II · Z-1424-2017: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
- Feb 20, 2017 · Class II · Z-1425-2017: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
- Feb 20, 2017 · Class II · Z-1423-2017: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
- Feb 20, 2017 · Class II · Z-1422-2017: The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
- Apr 22, 2016 · Class II · Z-2035-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2006-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2032-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2037-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2007-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2027-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2025-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2024-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2030-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2008-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2015-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2018-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2014-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2031-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2033-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2012-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2026-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2010-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2029-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2016-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2011-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2036-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2019-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2020-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2022-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2034-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2023-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2017-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2021-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2005-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2013-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2009-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
- Apr 22, 2016 · Class II · Z-2028-2016: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

## Indications for use
The Siemens Biograph TruePoint 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.

Source page: https://510kreport.com/device/K141971
Methodology: https://510kreport.com/methodology