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NAEOTOM Alpha, Scan&GO Software

by Siemens Medical Solutions USA, Inc.

510(k) K220814

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220814 Date12 Jul 2022ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1003-2023 FDA Class II initiated 22 Dec 2022

    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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

NAEOTOM Alpha is a photon-counting CT scanner that utilizes Quantum Technology to enhance diagnostic results and processes across various clinical scenarios. It redefines high-resolution utilization in CT imaging by offering a new level of detail while minimizing radiation dose. The system includes AI-powered productivity solutions and provides full spectral and reconstruction possibilities.

The NAEOTOM Alpha, Scan&GO Software is manufactured by Siemens Medical Solutions USA, Inc. and is authorized under FDA 510K clearance with product code JAK. It is supplied as software for use with the NAEOTOM Alpha CT scanner systems. The device is designed to optimize kV and keV for photon-counting detector CT, including CARE keV functionality.

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