True 3D Viewer

System, Image Processing, Radiological

EchoPixel, Inc.

The following data is part of a premarket notification filed by Echopixel, Inc. with the FDA for True 3d Viewer.

Pre-market Notification Details

Device IDK201365
510k NumberK201365
Device Name:True 3D Viewer
ClassificationSystem, Image Processing, Radiological
Applicant EchoPixel, Inc. 4677 Old Ironsides Drive, Suite 445 Santa Clara,  CA  95054
ContactMichael Gabler
CorrespondentSheila Pickering
Sheila Pickering Consulting Group 2081 Longden Circle Los Altos,  CA  94024
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-22
Decision Date2020-07-17

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