# K071068: Biograph 6 Truepoint, Model Biograph 6 - P/N 10238197

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: May 14, 2007 after 28 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K002715 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060060: Biograph 6, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.
- K060631: Biograph 64 and Biograph 40, Siemens Medical Solutions USA, Inc. (2006) Summary page 1.

## Indications for use
The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The Biograph 6 PET/CT provides registration and fusion of high-resolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

Source page: https://510kreport.com/device/K071068
Methodology: https://510kreport.com/methodology