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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 K230150
Device Name OptimMRI
Applicant
RebrAIn, SAS
PTIB - Hôpital Xavier Arnozan - Avenue du Haut Lévêque
Pessac,  FR 33600
Applicant Contact Ram Bedi
Correspondent
RebrAIn, SAS
PTIB - Hôpital Xavier Arnozan - Avenue du Haut Lévêque
Pessac,  FR 33600
Correspondent Contact Ram Bedi
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received01/19/2023
Decision Date 07/21/2023
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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