# K130901: Somatom Definition as Open

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Jan 2, 2014 after 276 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: 5 generations back to K982349 (1998). 6 ancestors in all.
49 later devices descend from it; 6 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103127: Somatom Definition as, Siemens Medical Solutions USA, Inc. (2011) Summary page 2.

## Cited in the summary but kept off the family tree
- K2590321: Siemens SOMATOM Definition Edge. Number could not be read

## Most influential descendants
- K143401: SOMATOM Definition Edge (2015), 35 descendants of its own
- K143400: SOMATOM Definition AS/AS+ (2015), 32 descendants of its own
- K152036: SOMATOM Definition Edge, SOMATOM Definition AS/AS+ (2015), 28 descendants of its own
- K142955: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power (2015), 27 descendants of its own
- K143416: SOMATOM Definition Flash (VA48) (2015), 25 descendants of its own

## Indications for use
The Siemens SOMATOM Definition AS Open 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/K130901
Methodology: https://510kreport.com/methodology