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

    PATIENT DOSE MONITOR

    K Number: K912249 · Decision Aug 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    PATIENT DOSE MONITOR
    K Number
    K912249
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theta Systems, Inc.
    Date Received
    May 21, 1991
    Decision Date
    August 30, 1991
    Product Code
    KPZ
    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
    KPZ Generator, High Voltage, X-Ray, Therapeutic

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    Other Clearances by Theta Systems, Inc.

    K Number Device Name
    K912250 ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES