AI4CMR v2.0— 510(k) K252084

Name: FDA 510(k) clearance K252084
Creator: U.S. Food and Drug Administration
Published: 2026-02-11

Substantially Equivalent

Ai4medimaging Medical Solutions S.A.

FDA 510(k) clearance K252084 for AI4CMR v2.0, Substantially Equivalent on 2026-02-11. Applicant: Ai4medimaging Medical Solutions S.A.. Device class: 2.

Clearance details

Applicant: Ai4medimaging Medical Solutions S.A.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-07-02
Decision date: 2026-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Braga, PT

Download summary PDF View on FDA.gov ↗

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