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510(k) Data Aggregation

    K Number
    K112112
    Device Name
    SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
    Manufacturer
    SENTINEL MEDICAL, INC.
    Date Cleared
    2011-08-25

    (31 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SENTINEL MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sentinelle Breast MRI tabletop with 16 Channel Coil Array for Siemens 1.5T/3T MRI Systems is designed to provide magnetic resonance images of breast anatomy when used in conjunction with a Magnetic Resonance Scanner. These images are interpreted by a trained physician. When used with a disposable sterile plate (biopsy grid), the device permits access to breast anatomy for biopsy and localization procedures.
    Device Description
    The Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI Systems is a receive-only MRI imaging coil and interventional system for breast anatomy. The system consists of a tabletop which supports the patient and imaging coils which provide a means of enabling interventional device guidance. The tabletop, like other breast coils provides an aperture to admit the breasts and provides the physician access to the breast(s). This aperture enables the guidance of interventional devices (such as biopsy needles), when performing a biopsy. The tabletop's compression system facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). Compression plates (also referred to as immobilization plates) provided with the system are held in frames, which may be positioned in the left-right and anteriorposterior directions and fixed in place to gently immobilize one or both breasts for interventional procedures. When performing a stereotactic interventional procedure (such as biopsy or wire localization), one or more compression plates may be interchanged for a sterile, single use, disposable fenestrated plate (also referred to as biopsy grid) cleared under FDA 510(k) Number: K060873. The biopsy grid contains apertures that permit the physician to access the breast for intervention, while minimizing tissue motion. When performing biopsy and/or imaging of a single breast, the system may be used with two compression plates immobilizing that breast. The contralateral breast support prevents the contralateral breast from interfering with medial-approach interventions. When imaging both breasts, a medial coil element is used between the breasts in conjunction with two lateral coils. The tabletop's receive-only coil system acts to passively collect RF emissions from the nuclei excited by the MRI. The Sentinelle phased array breast coil set consists of 2, 10 or 16 RF coil elements in a phased array design. The coil elements and electronics are enclosed in a rigid housing that is resistant to fluid ingress and is fire retardant. The coils are positioned close to the patient's breast during imaging. This receive-only coil is designed to give an improved signal-to-noise ratio, image resolution and image acquisition over that of a standard body coil.
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