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510(k) Data Aggregation

    K Number
    K142107
    Device Name
    ECHO TRUE 3D VIEWER
    Manufacturer
    ECHO PIXEL INC.
    Date Cleared
    2015-01-21

    (173 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECHO PIXEL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as preoperative software for simulating surgical treatment options. The True 3D Viewer is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
    Device Description
    The True 3D 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. The t3D-Viewer software application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The t3D-Viewer software application enables HCPs to visualize and interact with image data and depictions of tissue and organs as if they were real physical objects.
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