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510(k) Data Aggregation

    K Number
    K964576
    Device Name
    PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
    Manufacturer
    BENNETT X-RAY CORP.
    Date Cleared
    1997-01-10

    (57 days)

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

    BENNETT X-RAY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bennett Profile mammography system, like the Bennett Contour M-CTR, LORAD M-IV, Instrumentarium Alpha RT, GE Senographe 700T and 800T, and Philips mammo DIAGNOST 3000 mammographic imaging systems, is a dedicated mammographic imaging system used for mammographic examinations.
    Device Description
    The Bennett Profile Mammographic System, Model M-PRO, is a dedicated mammographic imaging system used as an x-ray source in the performance of mammographic examinations and can be adapted for biopsy and spot mammographic examinations. It consists of the following components; an x-ray generator cabinet, Model M-1500G; tube stand with non-tilting C-arm; mammographic collimator (DM-1500) and tube; an operator control panel, Model M-1500C; and image receptor (film cassette holder or bucky). The Profile Mammography System is a microprocessor-controlled x-ray source requiring single-phase 200-240 VAC, 50/60 Hz for operation. The Profile system's C-arm is fully counterbalanced and is locked in position using electro-mechanical locks. The C-arm has a fixed source-to-image distance (SID) of 76 cm.
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