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

    DR5000 DEDICATED CHEST X-RAY SYSTEM

    K Number: K001341 · Decision Jun 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    32
    Review Days
    36

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    Basic Information

    Device Name
    DR5000 DEDICATED CHEST X-RAY SYSTEM
    K Number
    K001341
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Analogic Corp.
    Date Received
    April 27, 2000
    Decision Date
    June 2, 2000
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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