# K052216: Somatom Definition

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Sep 8, 2005 after 36 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013561 (2001). 5 ancestors in all.
38 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013522: Somatom P30 CT Systems, Siemens Medical Systems, Inc. (2001) Summary page 1.
- K040372: Lightspeed 7.0 CT Scanner System, Ge Medical Systems, LLC (2004) Summary page 1.

## Most influential descendants
- K082220: Somatom Flash DS (2008), 36 descendants of its own
- K113342: Somatom Definition Flash (2011), 32 descendants of its own
- K121072: Somatom Definition Flash (2012), 31 descendants of its own
- K133589: Somatom Force (2014), 29 descendants of its own
- K122471: Somatom Definition (2012), 28 descendants of its own

## Indications for use
The Siemens SOMATOM P45 systems are intended to produce 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. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Source page: https://510kreport.com/device/K052216
Methodology: https://510kreport.com/methodology