# K173632: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 13, 2018 after 140 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K013561 (2001). 34 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163296: SOMATOM go.Up, SOMATOM go.Now, Siemens Medical Solutions USA, Inc. (2017) Summary page 9.
- K163297: Scan&GO, Siemens Medical Solutions USA, Inc. (2017) Summary page 10.

## Most influential descendants
- 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
- K233650: SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed (2024), 5 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
- Sep 24, 2019 · Class II · Z-0265-2020: SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional
- Jul 31, 2019 · Class II · Z-2401-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jul 31, 2019 · Class II · Z-2399-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jul 31, 2019 · Class II · Z-2400-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jul 31, 2019 · Class II · Z-2404-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jul 31, 2019 · Class II · Z-2402-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jul 31, 2019 · Class II · Z-2403-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jul 31, 2019 · Class II · Z-2405-2019: The injector holder could potentially fall off together with the injector and the storage box.
- Jun 4, 2019 · Class II · Z-1919-2019: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
- Jun 4, 2019 · Class II · Z-1922-2019: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
- Jun 4, 2019 · Class II · Z-1921-2019: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
- Jun 4, 2019 · Class II · Z-1920-2019: The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
- May 28, 2019 · Class II · Z-1915-2019: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
- May 28, 2019 · Class II · Z-1917-2019: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
- May 28, 2019 · Class II · Z-1918-2019: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.
- May 28, 2019 · Class II · Z-1916-2019: The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

## 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. 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. 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. 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. 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. 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. 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. 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. The in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner. The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols

Source page: https://510kreport.com/device/K173632
Methodology: https://510kreport.com/methodology