AI4CMR v2.0— 510(k) K252084

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..

Clearance details

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

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