syngo Dynamics (VA41F)— 510(k) K253689
Substantially EquivalentSiemens Healthcare GmbH
FDA 510(k) clearance K253689 for syngo Dynamics (VA41F), Substantially Equivalent on 2026-04-10. Applicant: Siemens Healthcare GmbH.
Summary
Syngo Dynamics (VA41F) is Siemens Healthineers' cardiovascular image management platform — the version suffix "VA41F" indicates a software release update to a cleared platform. Product code QIH covers radiological image management / PACS-adjacent software.
Radiology panel, Traditional 510(k). Cardiovascular PACS sit in an odd regulatory place — they're cleared under radiology product codes but target echo labs, cath labs, and hemodynamic workflows. Software-version 510(k)s for this category typically clear incremental feature sets and bug fixes rather than new analytics.
Siemens Healthcare GmbH, Erlangen. Five-month review clock. Siemens files frequently on both QIH and QKB for different product lines within the imaging portfolio.
Clearance details
- Applicant
- Siemens Healthcare GmbH
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Erlanger, DE
Data sourced from openFDA. This site is unofficial and independent of the FDA.