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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 K242054
Device Name OptimMRI (v2)
Applicant
Rebrain, SAS
Plateforme Technologique d’Innovation Biomédicale (PTIB)
Hôpital Xavier Arnozan Avenue du Haut Lévêque
Pessac,  FR 33600
Applicant Contact Thomas Queuche
Correspondent
Rebrain, SAS
Plateforme Technologique d’Innovation Biomédicale (PTIB)
Hôpital Xavier Arnozan Avenue du Haut Lévêque
Pessac,  FR 33600
Correspondent Contact Thomas Queuche
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/15/2024
Decision Date 08/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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