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

    PVMED DDR 2520 DIGITAL IMAGING SYSTEM

    K Number: K072766 · Decision Dec 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    PVMED DDR 2520 DIGITAL IMAGING SYSTEM
    K Number
    K072766
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1630
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portavision Medical
    Date Received
    September 28, 2007
    Decision Date
    December 11, 2007
    Product Code
    IXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    IXK System, Imaging, X-Ray, Electrostatic

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