# K143401: SOMATOM Definition Edge

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 6, 2015 after 129 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K982349 (1998). 8 ancestors in all.
35 later devices descend from it; 5 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120579: Somatom Definition Edge, Siemens Medical Systems, Inc. (2012) Summary page 5.
- K130901: Somatom Definition as Open, Siemens Medical Systems, Inc. (2014) Summary page 5.

## Most influential descendants
- K152036: SOMATOM Definition Edge, SOMATOM Definition AS/AS+ (2015), 28 descendants of its own
- K173630: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence (2018), 20 descendants of its own
- 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

## Recalls of this device
- Jul 25, 2019 · Class II · Z-2440-2019: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifi
- Jul 13, 2016 · Class II · Z-2626-2016: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is
- Aug 14, 2015 · Class II · Z-0019-2016: software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve a

## Indications for use
The Siemens SOMATOM Definition Edge (Project PA6F) 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 simultancous translation of the patient.)

Source page: https://510kreport.com/device/K143401
Methodology: https://510kreport.com/methodology