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syngo Dynamics Version VA30

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171053

by Siemens Healthcare GmbH

Identifiers

510(k) Number
K171053 FDA 510(k)
FDA Product Code
LLZ 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 Version VA30 is a Cardiology Picture Archiving and Communication System (PACS) and integrated information system designed for the acceptance, transfer, display, storage, archiving, and manipulation of digital medical images. It facilitates the review, analysis, quantification, and reporting of cardiovascular examinations, supporting clinical decision-making in healthcare settings.

This software-based system is supplied as a standalone solution for integration within radiology and cardiology workflows. It operates in non-sterile environments and is intended for use in MRI-safe settings, adhering to regulatory standards under FDA 510(k) clearance (K171053) and EU MDR compliance. No single-use or reusable classifications apply, as it is a software-based medical device. Storage and deployment require compliance with institutional IT infrastructure and imaging protocol standards.

Frequently asked questions

What types of medical images and workflows does syngo Dynamics Version VA30 support in cardiology and radiology settings?

syngo Dynamics Version VA30 is designed to handle digital medical images related to cardiovascular examinations, enabling review, analysis, quantification, and reporting. It integrates into radiology and cardiology workflows to support the storage, archiving, and manipulation of these images, aiding clinical decision-making. The system is tailored for MRI-safe environments and facilitates the transfer and display of imaging data within healthcare IT infrastructure.

Is syngo Dynamics Version VA30 a single-use or reusable device, and how should it be handled in a clinical environment?

syngo Dynamics Version VA30 is a software-based medical device and does not fall under single-use or reusable classifications. Since it operates in non-sterile environments, it requires proper IT infrastructure setup and adherence to institutional imaging protocols for deployment. No physical handling or sterilization procedures apply, as it is entirely digital.

What regulatory pathways does syngo Dynamics Version VA30 follow, and how does this affect its use in the U.S. and EU?

syngo Dynamics Version VA30 is cleared under the FDA’s 510(k) pathway with the designation K171053, classified as substantially equivalent to a predicate device in the radiology category. In the EU, it complies with the Medical Device Regulation (MDR). These pathways ensure the device meets regulatory standards for safety and performance in both markets, but they do not define clinical indications—only that it is intended for use in MRI-safe settings for image management.

How does syngo Dynamics Version VA30 integrate into existing hospital systems, and what infrastructure requirements does it have?

syngo Dynamics Version VA30 is supplied as a standalone software solution intended for integration within radiology and cardiology workflows. It requires compliance with institutional IT infrastructure standards and imaging protocols for deployment. Since it is MRI-safe, it must be deployed in environments where electromagnetic interference risks are managed, but no additional hardware beyond standard IT systems is specified.

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, PDF K171053 syngo Dynamics Version VA30 - 510kdatabase.net, syngo Dynamics Version VA30 (K171053) — FDA 510(k) | Innolitics, Syngo Dynamics Version VA30 510(k) K171053 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (2)

  • FDA 510(k) K171053 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 29, 2026