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    K Number
    K964485
    Device Name
    PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
    Manufacturer
    ELIAV LTD.
    Date Cleared
    1997-02-04

    (88 days)

    Product Code
    IYE,IYG,JAE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    The PORTpro is a free-standing, digital camera based electronic portal imaging device (EPID) for use as an accessory to existing x-radiation therapy systems operating in the megavoltage range (1 - 15 MeV). The PORTpro displays high quality portal images on a computer monitor in virtually real time and also provides archiving and image processing capabilities.

    AI/ML Overview

    This document describes the PORTpro Electronic Portal Imaging System, a device used as an accessory to x-radiation therapy systems. However, the provided text does not contain any information regarding acceptance criteria, studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is missing from the provided input.

    The document primarily focuses on the device's description, its predicate devices, and a comparison of its technological characteristics. It mentions that "The differences between the systems raise no new issues of safety or effectiveness," but does not provide any data or studies to support this claim or any other performance claim.

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