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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
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