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

    Kubtec Mozart Supra (XPERT 84) Radiography System

    K Number: K210955 · Decision Sep 20, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    10
    Review Days
    174

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    Basic Information

    Device Name
    Kubtec Mozart Supra (XPERT 84) Radiography System
    K Number
    K210955
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kub Technologies, Inc.
    Date Received
    March 30, 2021
    Decision Date
    September 20, 2021
    Product Code
    MWP
    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
    MWP Cabinet, X-Ray System

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    Other Clearances by Kub Technologies, Inc.

    K Number Device Name
    K210957 Kubec Xpert 80 Radiography System
    K210956 Kubtec Mozart (XPERT42)
    K200756 Kubtec Mozart Supra
    K183624 Kubtec Mozart (Xpert42)
    K151221 Kubtec DIGIVIEW 395
    K141539 KUBTEC X250
    K103348 DIGIVIEW 250
    K083510 KUBTEC XPERT 20
    K071233 XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM