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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 K230552
Device Name MR DWI/FLAIR Measurement V1.0
Olea Medical
93 Avenue des Sorbiers, ZI ATHELIA IV
La Ciotat,  FR 13600
Applicant Contact Nathalie Palumbo
Hogan Lovells US LLP
Columbia Square 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2050
Classification Product Code
Date Received02/28/2023
Decision Date 04/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No