# K113342: Somatom Definition Flash

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Dec 29, 2011 after 45 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K013561 (2001). 10 ancestors in all.
32 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082220: Somatom Flash DS, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K121072: Somatom Definition Flash (2012), 31 descendants of its own
- K133589: Somatom Force (2014), 29 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
- K161196: SOMATOM Drive (2016), 24 descendants of its own

## Recalls of this device
- Nov 15, 2013 · Class II · Z-0907-2014: During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo C

## Indications for use
The Siemens SOMATOM Definition Flash (with Stellar Detector) system is 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. In addition the SOMATOM Definition Flash (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images. The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Source page: https://510kreport.com/device/K113342
Methodology: https://510kreport.com/methodology