# K121072: Somatom Definition Flash

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Systems, Inc.
- Decided: May 8, 2012 after 29 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K013561 (2001). 11 ancestors in all.
31 later devices descend from it; 4 cite 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.
- K113342: Somatom Definition Flash, Siemens Medical Systems, Inc. (2011) Summary page 2.

## Most influential descendants
- 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
- K162302: Somatom Confidence ® RT Pro (2016), 21 descendants of its own

## Recalls of this device
- Nov 24, 2020 · Class II · Z-0771-2021: System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
- Jun 22, 2020 · Class II · Z-3025-2020: Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan
- Oct 7, 2019 · Class II · Z-0406-2020: Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes
- Oct 19, 2016 · Class II · Z-0605-2017: A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becom
- Mar 2, 2016 · Class II · Z-1520-2016: Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of addit

## Indications for use
The Siemens SOMATOM Definition Flash 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 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/K121072
Methodology: https://510kreport.com/methodology