# K220814: NAEOTOM Alpha, Scan&GO Software

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 12, 2022 after 113 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K013561 (2001). 48 ancestors in all.
3 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)
- K211591: NAEOTOM Alpha, Scan&GO, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.
- 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, Siemens Medical Solutions USA, Inc. (2021) Summary page 5.

## Most influential descendants
- K233657: NAEOTOM Alpha (2024), 2 descendants of its own
- K243523: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (2025), 1 descendant of its own
- K251061: NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime (2025), 0 descendants of its own

## Recalls of this device
- Dec 22, 2022 · Class II · Z-1003-2023: In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped

## Indications for use
NAEOTOM Alpha 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 staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. 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. Scan& GO This 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/K220814
Methodology: https://510kreport.com/methodology