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510(k) Data Aggregation

    K Number
    K201365
    Device Name
    True 3D Viewer
    Manufacturer
    EchoPixel, Inc.
    Date Cleared
    2020-07-17

    (56 days)

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

    EchoPixel, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI, XA and Ultrasound sources. It is also intended as software which provides visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the mentioned images. The True 3D Viewer software 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
    Not Found
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