BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    HealthCCSng

    K Number: K241440 · Decision Aug 19, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    HealthCCSng
    K Number
    K241440
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano-X AI , Ltd.
    Date Received
    May 21, 2024
    Decision Date
    August 19, 2024
    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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