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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 K142107
FOIA Releasable 510(k) K142107
Device Name ECHO TRUE 3D VIEWER
Applicant
ECHO PIXEL INC.
2490 HOSPITAL DR.
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 Received08/01/2014
Decision Date 01/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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