Cleared Traditional

syngo.via MI Workflows; Scenium; syngo MBF

K251528 · Siemens Medical Solutions USA, Inc. · Radiology
Jul 2025
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K251528 is an FDA 510(k) clearance for the syngo.via MI Workflows; Scenium; syngo MBF, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Siemens Medical Solutions USA, Inc. (Hiffman Estates, US). The FDA issued a Cleared decision on July 3, 2025, 45 days after receiving the submission on May 19, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251528 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2025
Decision Date July 03, 2025
Days to Decision 45 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.