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510(k) Data Aggregation

    K Number
    K991716
    Device Name
    HISPEED NX/I CT SCANNER SYSTEM
    Manufacturer
    GE MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-06-18

    (29 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K980169,K980176,K940606,K973168,K982004
    Why did this record match?
    Reference Devices :

    K980169, K980176, K940606, K973168, K982004

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

    The HiSpeed NX/i CT system and HiSpeed options are indicated for head and whole body x-ray computed tomography applications.

    Device Description

    The HiSpeed NX/i CT system and HiSpeed options consist of a gantry, patient support, operator console, computer and associated accessories.

    AI/ML Overview

    The provided text is a 510(k) summary for the GE HiSpeed NX/i CT scanner system, indicating that the device is substantially equivalent to previously marketed CT systems. However, this document does not contain the specific acceptance criteria or a study detailing the device's performance against such criteria. The document explicitly states that it does not result in new potential safety risks and performs as well as, or better than devices currently on the market, but it doesn't provide concrete metrics or a study report with performance data.

    Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information directly from the provided text. This document is a regulatory submission for market clearance based on substantial equivalence, not a detailed performance study report.

    In summary, the provided document (K991716) does not contain the information required to answer the prompt regarding acceptance criteria and performance study details.

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