BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    TrueFit Bolus

    K Number: K260308 · Decision Feb 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    255
    Applicant Total
    3
    Review Days
    20

    Basic Information

    Device Name
    TrueFit Bolus
    K Number
    K260308
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Adaptiiv Medical Technologies, Inc.
    Date Received
    January 30, 2026
    Decision Date
    February 19, 2026
    Product Code
    MUJ
    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
    MUJ System, Planning, Radiation Therapy Treatment

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    Other Clearances by Adaptiiv Medical Technologies, Inc.

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