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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 K143318
Device Name DR Systems Zero Download 3D Viewer (Z3D)
Applicant
DR Systems, Inc
10140 Mesa Rim Road
San Diego,  CA  92121
Applicant Contact Kimberly J Meade
Correspondent
DR Systems, Inc
10140 Mesa Rim Road
San Diego,  CA  92121
Correspondent Contact Kimberly J Meade
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/19/2014
Decision Date 03/10/2015
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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