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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 K170167
Device Name True 3D Viewer Software
Applicant
EchoPixel Inc.
2490 Hospital Drive, Suite 310
Mountain View,  CA  94040
Applicant Contact Sergio Aguirre
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/19/2017
Decision Date 03/03/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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