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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 K201365
Device Name True 3D Viewer
Applicant
Echopixel, Inc.
4677 Old Ironsides Dr., Suite 445
Santa Clara,  CA  95054
Applicant Contact Michael Gabler
Correspondent
Sheila Pickering Consulting Group
2081 Longden Cir.
Los Altos,  CA  94024
Correspondent Contact Sheila Pickering
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/22/2020
Decision Date 07/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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