BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000

    K Number: K853395 · Decision Nov 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000
    K Number
    K853395
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Raytheon Medical Systems
    Date Received
    August 12, 1985
    Decision Date
    November 1, 1985
    Product Code
    IZH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZH System, X-Ray, Mammographic

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