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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 K151957
Device Name BOX DICOM Viewer
Applicant
Box, Inc.
4440 El Camino Real
Los Altos,  CA  94022
Applicant Contact CRISPEN MAUNG
Correspondent
O Tech, Inc.
8317 Belew Dr.
Mckinney,  TX  75071
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/16/2015
Decision Date 09/01/2015
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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