# K152036: SOMATOM Definition Edge, SOMATOM Definition AS/AS+

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 9, 2015 after 79 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K982349 (1998). 10 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143400: SOMATOM Definition AS/AS+, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.
- K143401: SOMATOM Definition Edge, Siemens Medical Solutions USA, Inc. (2015) Summary page 5.

## Most influential descendants
- K173607: SOMATOM Edge Plus (2018), 20 descendants of its own
- K190578: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence (2019), 19 descendants of its own
- K192061: SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO (2019), 16 descendants of its own
- K191891: SOMATOM X.cite (2019), 15 descendants of its own
- K200524: SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO (2020), 14 descendants of its own

## Recalls of this device
- Nov 15, 2016 · Class II · Z-0742-2017: Software update that provides software and firmware bug-fixes to improve system performance
- Nov 15, 2016 · Class II · Z-0744-2017: Software update that provides software and firmware bug-fixes to improve system performance
- Nov 2, 2016 · Class II · Z-0606-2017: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with so
- Nov 2, 2016 · Class II · Z-0607-2017: Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with so

## Indications for use
The Siemens SOMATOM Definition Edge, SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of xray 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/K152036
Methodology: https://510kreport.com/methodology