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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 K151737
Device Name MedicVOD System
Applicant
Orpheus Medical , Ltd.
P.O. Box 15140
Haifa,  IL 31905
Applicant Contact Asaf Omer
Correspondent
Dohmen Life Sciences Services, LLC
11925 W I-70 Frontage Rd. N.
Suite 900
Wheat Ridge,  CO  80033
Correspondent Contact Ian Marsden
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/26/2015
Decision Date 02/25/2016
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
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