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    ECHOPIXEL, INC.

    FDA registration
    ECHOPIXEL, INC.·1 product·🇺🇸 United States

    True 3D Viewer

    FDA UDI
    ECHOPIXEL, INC.·00851325007003·Software: The True 3D Viewer Software is inten...

    TRUE 3D VIEWER SOFTWARE

    FDA Adverse Event
    Malfunction ·ECHOPIXEL, INC.·Product code LLZ·February 22, 2018

    TRUE 3D VIEWER SYSTEM

    FDA Adverse Event
    Malfunction ·ECHOPIXEL INC·Product code LLZ·April 22, 2016

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Recall
    Open, Classified ·Echopixel, Inc.·Product code LLZ·April 11, 2016

    True 3D Viewer, Model: EP-00003

    FDA Recall
    Open, Classified ·Echopixel, Inc.·Product code LLZ·February 21, 2018

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Enforcement
    Class II ·Ongoing·Echopixel, Inc.·May 28, 2025

    True 3D Viewer, Model: EP-00003

    FDA Enforcement
    Class II ·Ongoing·Echopixel, Inc.·May 28, 2025