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510(k) Data Aggregation

    K Number
    K974444
    Device Name
    NUMASTATION
    Manufacturer
    NUMA, INC.
    Date Cleared
    1998-02-13

    (80 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K923736
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer, it is used in planar and whole-body and SPECT imaging.

    Device Description

    The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer. The acquisition hardware is a microprocessor-based system and is separate from the host personal computer. It uses simple, window-based GUIs.

    AI/ML Overview

    The provided text describes the "NumaStation" device and its substantial equivalence to a predicate device, but it does not contain information about specific acceptance criteria, device performance, results of a study, or details about ground truth establishment or sample sizes.

    The document is a 510(k) submission summary for the NumaStation, a nuclear medicine data acquisition system. It focuses on demonstrating substantial equivalence to a predicate device (Gamma 600t) based on functional similarities and adherence to EMC and NEMA standards.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details. The text primarily addresses regulatory compliance through substantial equivalence, not performance metrics derived from a detailed study.

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