# K143409: SOMATOM Definition AS Open (VA48)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 26, 2015 after 118 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (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). 7 ancestors in all.
21 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130901: Somatom Definition as Open, Siemens Medical Systems, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- 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
- Oct 19, 2016 · Class II · Z-0373-2017: Hardware issue that may expose the User to a potential risk for serious injury due to exposure to rotating or electrical parts.
- Jul 13, 2016 · Class II · Z-2624-2016: 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

## 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/K143409
Methodology: https://510kreport.com/methodology