Cleared Traditional

syngo Dynamics (Version VA41D)

K242551 · Siemens Healthcare GmbH · Radiology

Apr 2025

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K242551 is an FDA 510(k) clearance for the syngo Dynamics (Version VA41D), a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on April 3, 2025, 219 days after receiving the submission on August 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K242551 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2024
Decision Date	April 03, 2025
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QIH — Automated Radiological Image Processing Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.