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510(k) Data Aggregation

    K Number
    K070611
    Device Name
    BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
    Manufacturer
    NOMOS CORP.
    Date Cleared
    2007-07-11

    (128 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6

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

    BAT can be used for the positioning of patients that are prescribed external beam radiation treatments to organs which are readily identifiable on ultrasound images. BAT can be used for general imaging for small organs (breast, thyroid, testes), abdominal, trans-esophageal (noncardiac), trans-rectal, trans-vaginal, and musculo-skeletal (superficial and conventional) applications.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the BAT device, indicating that the device has been found substantially equivalent to a legally marketed predicate device for its indicated uses.

    The letter lists the device name, regulation numbers, regulatory class, product codes, and the indications for use, but it does not detail:

    • Specific acceptance criteria.
    • Results of a performance study that quantitatively demonstrates the device meets certain metrics.
    • Information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot provide the requested table and information based on the text provided.

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