# K161196: SOMATOM Drive

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Aug 24, 2016 after 119 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: 9 generations back to K013561 (2001). 31 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143416: SOMATOM Definition Flash (VA48), Siemens Medical Solutions USA, Inc. (2015) Summary page 4.
- 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 5.

## 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
- K163297: Scan&GO (2017), 19 descendants of its own
- K163296: SOMATOM go.Up, SOMATOM go.Now (2017), 19 descendants of its own
- K173632: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO (2018), 18 descendants of its own

## Recalls of this device
- Nov 24, 2020 · Class II · Z-0771-2021: System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan
- 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
- Jul 3, 2019 · Class II · Z-2271-2019: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

## 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. 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/K161196
Methodology: https://510kreport.com/methodology