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510(k) K193149

True 3D Viewer Software by Echopixel, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2019
Date Received
November 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Echopixel, Inc.

  • K201365 — True 3D Viewer (July 17, 2020)
  • K170167 — True 3D Viewer Software (March 3, 2017)
  • K142107 — ECHO TRUE 3D VIEWER (January 21, 2015)

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