syngo Dynamics (VA41F)— 510(k) K253689

Name: FDA 510(k) clearance K253689
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K253689 for syngo Dynamics (VA41F), Substantially Equivalent on 2026-04-10. Applicant: Siemens Healthcare GmbH. Device class: 2.

Summary

syngo Dynamics (VA41F) is Siemens software filed under QIH, automated radiological image processing software. The code covers AI-based image processing and analysis tools. The record doesn't describe what this software does, and it doesn't explain the VA41F label.

Class II, 21 CFR 892.2050. The Radiology panel reviewed it as a Traditional 510(k).

Siemens Healthcare GmbH filed from Germany, and the record gives the city as "Erlanger." Review took 140 days (November 21, 2025 to April 10, 2026).

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: Product code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-21
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlanger, DE

Download summary PDF View on FDA.gov ↗

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