BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    DIGORA

    K Number: K934949 · Decision Feb 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    4
    Review Days
    115

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    Basic Information

    Device Name
    DIGORA
    K Number
    K934949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1630
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Corporation Soredex
    Date Received
    October 18, 1993
    Decision Date
    February 10, 1994
    Product Code
    IXK
    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
    IXK System, Imaging, X-Ray, Electrostatic

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    Other Clearances by Orion Corporation Soredex

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