# K120579: Somatom Definition Edge

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Systems, Inc.
- Decided: May 23, 2012 after 86 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
No predicates in its family tree.
122 later devices descend from it; 6 cite it directly.
1 of 123 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K123920: Syngo.Via (2013), 63 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 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

## Recalls of this device
- Jul 3, 2019 · Class II · Z-2269-2019: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
- Mar 2, 2016 · Class II · Z-1521-2016: 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
- 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

Source page: https://510kreport.com/device/K120579
Methodology: https://510kreport.com/methodology