# K082220: Somatom Flash DS

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 10, 2008 after 65 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: 4 generations back to K013561 (2001). 9 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081022: Somatom Definition, Model as/as+, Siemens Medical Solutions USA, Inc. (2008) Summary page 2.
- K052216: Somatom Definition, Siemens Medical Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- 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 P47 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 P47 is able to produce additional image planes and analysis results by executing optional postprocessing 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/K082220
Methodology: https://510kreport.com/methodology