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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K160518
Device Name LEONI ORION System
Applicant
Leoni Cia Cable System
5 Ave. Victor Hugo
Chartres,  FR 28000
Applicant Contact AURELIE GENHO
Correspondent
Leoni Cia Cable System
5 Ave. Victor Hugo
Chartres,  FR 28000
Correspondent Contact AURELIE GENHO
Regulation Number892.5770
Classification Product Code
JAI  
Date Received02/24/2016
Decision Date 07/14/2016
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
Recalls CDRH Recalls
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