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Echopixel, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1785-2025Class IITrue 3D Viewer, Model: EP-00003February 21, 2018
Z-1807-2025Class IITRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-VApril 11, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K201365True 3D ViewerJuly 17, 2020
K193149True 3D Viewer SoftwareDecember 27, 2019
K170167True 3D Viewer SoftwareMarch 3, 2017
K142107ECHO TRUE 3D VIEWERJanuary 21, 2015