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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K220624
Device Name AI4CMR v1.0
Applicant
Ai4medimaging Medical Solutions S.A.
Rua Do Parque Poente, Lote 35
Braga,  PT 4705-002
Applicant Contact Carla Almeida
Correspondent
Ai4medimaging Medical Solutions S.A.
Rua Do Parque Poente, Lote 35
Braga,  PT 4705-002
Correspondent Contact Carla Almeida
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/03/2022
Decision Date 07/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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