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

    SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600

    K Number: K052447 · Decision Sep 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    32
    Review Days
    14

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    Basic Information

    Device Name
    SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
    K Number
    K052447
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Analogic Corp.
    Date Received
    September 7, 2005
    Decision Date
    September 21, 2005
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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