# K060631: Biograph 64 and Biograph 40

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 17, 2006 after 8 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K002715 (2000). 13 ancestors in all.
64 later devices descend from it; 4 cite it directly.
1 of 78 devices in its family (counting itself) has 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.
- K050509: Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64I, Cti Pet Systems, Inc. (2005) Summary page 1.
- K040665: Somatom Sensation 64 and Sensation Cardiac, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K081453: Biograph HD Family (2008), 62 descendants of its own
- K101550: Biograph MCT Family (2010), 38 descendants of its own
- K113448: Biograph MCT Family (2011), 37 descendants of its own
- K123737: Biograph MCT Family (2013), 36 descendants of its own
- K151486: Biograph mCT and mCT Flow PET/CT Scanners (2015), 34 descendants of its own

## Recalls of this device
- Aug 11, 2009 · Not classified · Z-0162-2010: In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
- Aug 11, 2009 · Not classified · Z-0163-2010: In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
- Aug 11, 2009 · Not classified · Z-0164-2010: In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.

## Indications for use
The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 64 and 40 are 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 X-Ray transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles. The Biograph 64 and 40 PET/CTs provide 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/K060631
Methodology: https://510kreport.com/methodology