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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 K243681
Device Name Neuro Insight V1.0
Applicant
Olea Medical S.A.S.
93 Ave. Des Sorbiers
Zi Athelia Iv
La Ciotat,  FR 13600
Applicant Contact Nathalie Palumbo
Correspondent
Hogan Lovells US LLP
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/29/2024
Decision Date 07/23/2025
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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