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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 K132095
Device Name OLEA SPHERE
Applicant
Olea Medical
93 Ave. Des Sorbiers, Zone Athelia Iv
La Ciotat,  FR 13600
Applicant Contact CAROLINE LENE
Correspondent
Olea Medical
93 Ave. Des Sorbiers, Zone Athelia Iv
La Ciotat,  FR 13600
Correspondent Contact CAROLINE LENE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/08/2013
Decision Date 12/26/2013
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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