Cleared Traditional

AI4CMR v1.0

K220624 · Ai4medimaging Medical Solutions S.A. · Radiology
Jul 2022
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K220624 is an FDA 510(k) clearance for the AI4CMR v1.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Ai4medimaging Medical Solutions S.A. (Braga, PT). The FDA issued a Cleared decision on July 22, 2022, 141 days after receiving the submission on March 3, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K220624 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2022
Decision Date July 22, 2022
Days to Decision 141 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050