Functional MR V1.0

System, Image Processing, Radiological

Olea Medical SAS

The following data is part of a premarket notification filed by Olea Medical Sas with the FDA for Functional Mr V1.0.

Pre-market Notification Details

Device IDK221426
510k NumberK221426
Device Name:Functional MR V1.0
ClassificationSystem, Image Processing, Radiological
Applicant Olea Medical SAS 93 Avenue Des Sorbiersm ZI ATHELIA IV La Ciotat,  FR 13600
ContactNathalie Palumbo
CorrespondentJohn J. Smith
Hogan Lovells US LLP Columbia Square 555 Thirteenth Street NW Washington,  DC  20004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-16
Decision Date2022-07-06

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