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510(k) Data Aggregation

    K Number
    K073262
    Device Name
    BELLA
    Manufacturer
    BEEKLEY CORP.
    Date Cleared
    2008-03-26

    (127 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEEKLEY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality. Indications for Use: To be applied to the mammography receptor plate, one per patient
    Device Description
    Bella is to be used on the bucky or the imaging receptor plate of mammography imaging equipment where the breast is placed for mammograms. The purpose of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality. Bella is designed to include a non-woven fabric type material that will feel like fabric on the skin. The material is non-compressable and the sizes are to include all leading mammography equipment for small and large buckies. Bella includes printed graphics to aid in the mental comforting of the patient. There is adhesive backing to Bella which allows easy application and removal from the bucky. The material and adhesive do not affect imaging.
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    K Number
    K020624
    Device Name
    BREAST BOLSTER
    Manufacturer
    BEEKLEY CORP.
    Date Cleared
    2002-09-12

    (198 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEEKLEY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.
    Device Description
    Not Found
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