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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252084
Device Name AI4CMR v2.0
Applicant
Ai4medimaging Medical Solutions S.A.
Rua Do Parque Poente, Lote 35
Braga,  PT 4705-002
Applicant Contact Carla Almeida
Correspondent
Meditec Consulting GmbH
Obermoosstrasse 23
Boll,  CH 3067
Correspondent Contact Sandra Soniec
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/02/2025
Decision Date 02/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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