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 is Siemens Healthineers' cardiovascular imaging and reporting software, used mostly in echo and cath labs. VA41F is a software version number. It's filed under QIH, automated radiological image processing software.

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

Siemens Healthcare GmbH filed from Erlangen, Germany (FDA's record spells it "Erlanger"). Review took 140 days (November 21, 2025 to April 10, 2026), a reasonable timeline for a version update to established software.

Clearance details

Applicant: Siemens Healthcare GmbH
Product code: 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.