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

    PHOTON RADIOSURGERY SYSTEM (PRS)

    K Number: K992577 · Decision Sep 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    52

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    Basic Information

    Device Name
    PHOTON RADIOSURGERY SYSTEM (PRS)
    K Number
    K992577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Photoelectron Corporation
    Date Received
    August 2, 1999
    Decision Date
    September 23, 1999
    Product Code
    JAD
    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
    JAD System, Therapeutic, X-Ray

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    Other Clearances by Photoelectron Corporation

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    K964947 PHOTON RADIOSURGERY SYSTEM (PRS)