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

    FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50

    K Number: K061361 · Decision Aug 15, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
    K Number
    K061361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Faxitron X-Ray Corp.
    Date Received
    May 16, 2006
    Decision Date
    August 15, 2006
    Product Code
    MWP
    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
    MWP Cabinet, X-Ray System

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    Other Clearances by Faxitron X-Ray Corp.

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    K072557 FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20