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

    I-LOGIC INREACH SYSTEM

    K Number: K102604 · Decision Oct 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    10
    Review Days
    27

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    Basic Information

    Device Name
    I-LOGIC INREACH SYSTEM
    K Number
    K102604
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Superdimension, Ltd.
    Date Received
    September 10, 2010
    Decision Date
    October 7, 2010
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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