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510(k) Data Aggregation

    K Number
    K964583
    Device Name
    XRT-7.0
    Manufacturer
    ELSCINT, INC.
    Date Cleared
    1997-01-17

    (63 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K945512
    Why did this record match?
    Reference Devices :

    K945512

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

    Not Found

    Device Description

    XRT-7.0 option was added to CT Twin flash. The option adds an Xray tube with 7.0 MHU anode heat capacity to the options list.

    AI/ML Overview

    This document does not describe an AI/ML powered device and therefore lacks the information necessary to answer the questions about acceptance criteria and study details for such a device.

    The document describes an X-ray tube option (XRT-7.0) for CT scanners. It's an engineering change to a piece of hardware (increasing the anode heat capacity of an X-ray tube).

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
    2. Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth, as these are concepts relevant to evaluating AI/ML models, not hardware components.
    3. Information on training sets or how their ground truth was established, as this is also specific to AI/ML model development.

    The "Effectiveness" section explicitly states: "The effectiveness of the device was not significantly changed in respect to the predicate device. CT Twin flash: The increased heat capacity is more convenient to use due to shorter delays for tube cooling." This further confirms it's a hardware enhancement related to operational convenience, not a new diagnostic or analytical capability powered by AI.

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