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510(k) Data Aggregation

    K Number
    K052704
    Device Name
    MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
    Manufacturer
    INVIVO CORP.
    Date Cleared
    2005-11-03

    (36 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE

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

    To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

    Device Description

    Model BBD Breast Immobilization and Biopsy Device

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "Model BBD Breast Immobilization and Biopsy Device." This document primarily focuses on regulatory approval and substantial equivalence to a predicate device.

    It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device can be marketed based on its substantial equivalence to previously approved devices, but it does not detail any performance metrics, study designs, sample sizes, or ground truth methodologies that would be required to answer your specific questions.

    Therefore, I cannot extract the requested information from the provided text.

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