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

    MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)

    K Number: K090182 · Decision May 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    255
    Applicant Total
    2
    Review Days
    98

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
    K Number
    K090182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuclemed S.A.
    Date Received
    January 26, 2009
    Decision Date
    May 4, 2009
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MUJ), ordered by most recent decision date.

    RadOncAI

    FDA 510(k)
    FDA Class 2 ·Radiology

    Multimodality Simulation Workspace (MM Sim) (v1.0.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    eXaSkin Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    ART.1-US

    FDA 510(k)
    FDA Class 2 ·Radiology

    syngo.via RT Image Suite VC10

    FDA 510(k)
    FDA Class 2 ·Radiology

    TrueFit Bolus

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Nuclemed S.A.

    K Number Device Name
    K090190 WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM