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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
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a device called "True 3D Viewer Software." It outlines the device's intended use and regulatory classification but does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the input text. The text does not describe a study that proves the device meets specific acceptance criteria.

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