# K103127: Somatom Definition as

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 4, 2011 after 133 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982349 (1998). 5 ancestors in all.
53 later devices descend from it; 2 cite it directly.
0 of 59 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.

## Most influential descendants
- K130901: Somatom Definition as Open (2014), 49 descendants of its own
- 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

## 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
- Jul 3, 2019 · Class II · Z-2268-2019: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
- Feb 14, 2019 · Class II · Z-1247-2019: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray 
- 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 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/K103127
Methodology: https://510kreport.com/methodology