# K163296: SOMATOM go.Up, SOMATOM go.Now

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 21, 2017 after 119 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 6 (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). 32 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 52 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 5.
- K161196: SOMATOM Drive, Siemens Medical Solutions USA, Inc. (2016) Summary page 5.

## Most influential descendants
- K173632: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO (2018), 18 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
- Mar 7, 2022 · Class II · Z-0962-2022: Software error may result in sporadic problems causing scanning workflow interruptions, unexpected user notifications and image artifacts. Sporadic software errors may also occur during interventional
- Mar 3, 2021 · Class II · Z-1253-2021: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in d
- Apr 20, 2018 · Class II · Z-1940-2018: There is a potential for a software issue that may cause the need for necessary patient rescans.
- Apr 20, 2018 · Class II · Z-1939-2018: There is a potential for a software issue that may cause the need for necessary patient rescans.
- Oct 2, 2017 · Class II · Z-0713-2018: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.
- Oct 2, 2017 · Class II · Z-0714-2018: The table may become unstable if the nuts on the bolts were not adequately tightened and thus have the potential to loosen and several bolts may gradually loosen at the same time.

## 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. High risk populations are 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/K163296
Methodology: https://510kreport.com/methodology