syngo Dynamics (VA41F)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253689 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
syngo Dynamics (VA41F) is a software-only Medical Image Management and Processing System (MIMPS) designed for cardiology applications. It processes and analyzes DICOM images from modalities such as ultrasound, x-ray angiography, CT, MR, and nuclear medicine to support diagnostic workflows in professional healthcare settings.
The device operates on standard IT hardware and is intended for use in clinical environments where cardiovascular imaging and reporting are performed. It is supplied as a software solution with no physical components, adhering to FDA 510(k) clearance (K253689) under the Traditional pathway and MDR compliance. No sterility, single-use, or MRI safety considerations apply, as it is a non-invasive, software-driven system.
Frequently asked questions
What is the primary purpose of syngo Dynamics (VA41F)?
syngo Dynamics (VA41F) is a software-only Medical Image Management and Processing System designed specifically for cardiology applications. It processes and analyzes DICOM images from various modalities including ultrasound, x-ray angiography, CT, MR, and nuclear medicine to support diagnostic workflows in professional healthcare settings.
How is syngo Dynamics (VA41F) supplied and what hardware requirements does it have?
The device is supplied as a software-only solution with no physical components. It operates on standard IT hardware and is intended for use in clinical environments where cardiovascular imaging and reporting are performed, making it compatible with existing hospital IT infrastructure.
What regulatory approvals does syngo Dynamics (VA41F) have?
syngo Dynamics (VA41F) has FDA 510(k) clearance under K253689 and is MDR compliant. It follows the Traditional pathway for regulatory submission and is classified under product code QIH with a review advisory committee of Radiology (RA).
Are there any sterility, single-use, or MRI safety considerations for syngo Dynamics (VA41F)?
No sterility, single-use, or MRI safety considerations apply to syngo Dynamics (VA41F) as it is a non-invasive, software-driven system that operates on standard IT hardware without any physical components that would require such considerations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: syngo Dynamics - Siemens Healthineers, syngo Dynamics (VA41F) (K253689) — FDA 510(k) | Innolitics, K253689 FDA 510 (k) - syngo Dynamics (VA41F), syngo Dynamics (VA41F) 510 (k) K253689 - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253689 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (2)
- FDA 510(k) K253689 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026