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510(k) Data Aggregation

    K Number
    K022240
    Device Name
    MOBILE MILLENNIUM MG SYSTEM
    Manufacturer
    GE MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-08-06

    (26 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K962738,K000395
    Why did this record match?
    Device Name :

    MOBILE MILLENNIUM MG SYSTEM

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

    The Mobile Millennium MG Imaging System is intended for use as a diagnostic imaging system which, when used with appropriate radiopharmaceuticals, produces images representative of the internal distribution of radioactivity in the head or body. It is designed to acquire, display, process, archive, and communicate data for whole body, planar, tomographic (SPECT), multislice, and attenuation corrected images. The system allows for the acquisition of data for high resolution three dimensional, static, gated, or dynamic images of biochemical and metabolic processes. It can be operated in a mobile as well as a fixed site environment.

    Device Description

    The GE Millennium Mobile MG System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, a processing and review workstation, and associated accessories. Materials and construction are equivalent to the Millennium MG System and eNTEGRA Workstation and are compliant with CISPR 11, IEC 801, UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) summary for a medical device (Millennium Mobile MG Imaging System and eNTEGRA Workstation) and primarily focuses on demonstrating substantial equivalence to a predicate device.

    The "Summary of Studies" section states: "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards." However, it does not provide:

    • A table of specific acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any performance studies.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study proving the device meets them based on the provided text.

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