# K173578: Biograph mCT Family of PET/CT Systems

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 20, 2017 after 30 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K002715 (2000). 19 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151486: Biograph mCT and mCT Flow PET/CT Scanners, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K180811: Biograph Vision (2018), 8 descendants of its own
- K190900: Biograph Vision (2019), 7 descendants of its own
- K193248: Biograph Vision, Biograph mCT Family of PET/CTs (2020), 6 descendants of its own
- K233677: Biograph VK10 (2024), 1 descendant of its own
- K210262: Biograph Vision Quadra PET/CT System (2021), 1 descendant of its own

## Recalls of this device
- Sep 28, 2018 · Class II · Z-0178-2019: The terminals on the plug may become loose and overheat.
- May 29, 2018 · Class II · Z-2248-2018: Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our supplier that some laser cover windows may fall off a limited population of the Biograph mCT and Biograph

## Indications for use
Siemens 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 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 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 healthcare 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. This CT system can be used for low dose lung cancer screening in high risk populations. (High risk population has been defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.)

Source page: https://510kreport.com/device/K173578
Methodology: https://510kreport.com/methodology