BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

    K Number: K223794 · Decision Jan 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    133
    Applicant Total
    21
    Review Days
    29

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    Basic Information

    Device Name
    hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
    K Number
    K223794
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cefla S.C.
    Date Received
    December 19, 2022
    Decision Date
    January 17, 2023
    Product Code
    OAS
    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
    OAS X-Ray, Tomography, Computed, Dental

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    Other Clearances by Cefla S.C.

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