# K173630: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 30, 2018 after 126 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: 10 generations back to K013561 (2001). 36 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Siemens Medical Solutions USA, Inc. (2015) Summary page 12.
- K161196: SOMATOM Drive, Siemens Medical Solutions USA, Inc. (2016) Summary page 12.
- K143401: SOMATOM Definition Edge, Siemens Medical Solutions USA, Inc. (2015) Summary page 12.
- K133589: Somatom Force, Siemens Medical Solutions USA, Inc. (2014) Summary page 12.
- K143416: SOMATOM Definition Flash (VA48), Siemens Medical Solutions USA, Inc. (2015) Summary page 12.
- K143400: SOMATOM Definition AS/AS+, Siemens Medical Solutions USA, Inc. (2015) Summary page 13.
- K143409: SOMATOM Definition AS Open (VA48), Siemens Medical Solutions USA, Inc. (2015) Summary page 13.
- K162302: Somatom Confidence ® RT Pro, Siemens Medical Solutions USA, Inc. (2016) Summary page 13.

## Most influential descendants
- 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
- K211373: SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software (2021), 12 descendants of its own

## Recalls of this device
- 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
- Feb 14, 2019 · Class II · Z-1244-2019: 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 
- Feb 14, 2019 · Class II · Z-1245-2019: 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 

## Indications for use
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations.* *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Source page: https://510kreport.com/device/K173630
Methodology: https://510kreport.com/methodology