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510(k) Data Aggregation

    K Number
    K021491
    Device Name
    HISPEED DUAL
    Manufacturer
    GE MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-05-22

    (13 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K993645
    Why did this record match?
    Device Name :

    HISPEED DUAL

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

    The Hispeed CT/e Dual Computed Tomography System is indicated for head and whole body X-ray Computed Tomography applications.

    Device Description

    The Hispeed CT/e Dual Computed Tomography system consist of a gantry, patient support, operator console ,computer and associated accessories.

    AI/ML Overview

    This document is a 510(k) summary for the GE Healthcare Hispeed CT/e Dual Computed Tomography system. It asserts substantial equivalence to existing devices and outlines the device's intended use and safety standards. However, it does not contain information regarding detailed acceptance criteria, a study proving performance against such criteria, or any data related to AI/algorithm performance.

    Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating device performance based on the input text. The document focuses on regulatory compliance and substantial equivalence, not detailed performance studies or AI aspects.

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