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510(k) Data Aggregation

    K Number
    K041481
    Device Name
    MODEL BBC-127 BIOPSY BREAST COIL
    Manufacturer
    MRI DEVICES CORP.
    Date Cleared
    2004-07-19

    (46 days)

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

    MODEL BBC-127 BIOPSY BREAST COIL

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

    To be used in conjunction with a Magnetic Resonance Scanner to:

      1. Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
      1. Permit MR-quided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
    Device Description

    Model BBC-127 Biopsy Breast Coil

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Model BBC-127 Biopsy Breast Coil" and primarily addresses the regulatory approval process and indications for use.

    Therefore, I cannot provide the requested information about acceptance criteria or a study from this document.

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