BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    “BRAXX” Esophageal Brachytherapy Applicator

    K Number: K183332 · Decision Apr 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    203
    Applicant Total
    2
    Review Days
    134

    Basic Information

    Device Name
    “BRAXX” Esophageal Brachytherapy Applicator
    K Number
    K183332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BRAXX Biotech Co. Ltd
    Date Received
    December 3, 2018
    Decision Date
    April 16, 2019
    Product Code
    JAQ
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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    Other Clearances by BRAXX Biotech Co. Ltd

    K Number Device Name
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