← Back to catalogue

syngo Dynamics (Version VA41D)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242551

by Siemens Healthcare GmbH

Identifiers

510(k) Number
K242551 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 (Version VA41D) is a Medical Image Management and Processing System (Regulation Number: 21 CFR 892.2050, Product Code: QIH), designed for cardiovascular reading, reporting, and workflow streamlining in radiology. It facilitates enterprise-wide clinical decision support by integrating and processing medical imaging data for diagnostic evaluation.

This software-based system is intended for use in radiology departments and clinical imaging settings, supplied as a standalone application compatible with enterprise networks. It is classified as Class II under FDA regulations and has received FDA 510(k) clearance (K242551) as substantially equivalent to a predicate device. No sterility or single-use requirements apply, as it is a reusable digital solution.

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 (Version VA41D) (K242551) — FDA 510 (k) | Innolitics, K242551 - syngo Dynamics (Version VA41D) FDA 510 (k) APPLICATION FOR ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (1)

  • FDA 510(k) K242551 24 fields · synced Oct 6, 2026