BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    MRI Planner

    K Number: K211841 · Decision Aug 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    255
    Applicant Total
    1
    Review Days
    437

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    Basic Information

    Device Name
    MRI Planner
    K Number
    K211841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectronic Medical AB
    Date Received
    June 14, 2021
    Decision Date
    August 25, 2022
    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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