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Syngo Dynamics (Version VA40F)

by Siemens Medical Solutions USA, Inc. 510(k)

Active United States

510(k) K222428

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222428 Date14 Nov 2022ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

Syngo Dynamics (Version VA40F) is a radiology AI listing for mammography and digital breast tomosynthesis (DBT). It is a software solution designed to support cardiovascular reading and reporting, streamlining workflows and aiding clinical decision-making across the enterprise.

The device is supplied as a software system and is authorized under FDA 510(k) clearance K222428, determined to be substantially equivalent to a predicate device. It is intended for use in clinical radiology settings and does not introduce new safety or effectiveness concerns compared to the identified predicate.

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Questions

AI-generated answers, 27 Sep 2026

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

  • What is Syngo Dynamics (Version VA40F) used for?

    Syngo Dynamics (Version VA40F) is a radiology AI software solution designed to support cardiovascular reading and reporting for mammography and digital breast tomosynthesis (DBT), streamlining workflows and aiding clinical decision-making in clinical radiology settings.

  • How is Syngo Dynamics (Version VA40F) supplied and deployed?

    Syngo Dynamics (Version VA40F) is supplied as a software system intended for use in clinical radiology environments, where it integrates into existing workflows to assist with image interpretation and reporting tasks.

  • Is Syngo Dynamics (Version VA40F) a single-use or reusable software system?

    Syngo Dynamics (Version VA40F) is a reusable software system, as it is designed for ongoing clinical use in radiology settings to support repeated readings and reporting over time without physical degradation or consumption.

  • What regulatory pathway was used for Syngo Dynamics (Version VA40F)?

    Syngo Dynamics (Version VA40F) received authorization through the FDA 510(k) pathway under clearance K222428, demonstrating substantial equivalence to a predicate device and confirming no new safety or effectiveness concerns.