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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K160301
Device Name Platinum dRF Imaging System
Applicant
Apelem-Dms Group
Parc Scientifique Georges Passe 175 Allee Von Neumann
Nimes 30005,  FR
Applicant Contact Krishna Mahadea
Correspondent
MEDIcept, Inc.
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact Sharyn Orton
Regulation Number892.1650
Classification Product Code
JAA  
Date Received02/04/2016
Decision Date 03/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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