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510(k) Data Aggregation

    K Number
    K990256
    Device Name
    CRX WORLD SHUNT
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1999-04-01

    (64 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K951925,K961459,K964617
    Why did this record match?
    Device Name :

    CRX WORLD SHUNT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.

    AI/ML Overview

    This 510(k) summary does not contain the information required to answer your request. It describes a software module for 3D visualization of ultrasound images but does not include details on acceptance criteria, study design, performance metrics, ground truth establishment, or sample sizes for testing or training. The document primarily focuses on identifying the device, its manufacturer, and predicate devices.

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