Cleared Special

AI4CMR v2.0

K252084 · Ai4medimaging Medical Solutions S.A. · Radiology
Feb 2026
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K252084 is an FDA 510(k) clearance for the AI4CMR v2.0, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Ai4medimaging Medical Solutions S.A. (Braga, PT). The FDA issued a Cleared decision on February 11, 2026, 224 days after receiving the submission on July 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K252084 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2025
Decision Date February 11, 2026
Days to Decision 224 days
Submission Type Special
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.