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

    Monaco RTP System

    K Number: K183037 · Decision Dec 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    51
    Same Product Code
    243
    Applicant Total
    2
    Review Days
    33

    Basic Information

    Device Name
    Monaco RTP System
    K Number
    K183037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elekta, Inc
    Date Received
    November 1, 2018
    Decision Date
    December 4, 2018
    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.

    RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

    FDA 510(k)
    FDA Class 2 ·Radiology

    RayCare (2024A SP1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Oncospace

    FDA 510(k)
    FDA Class 2 ·Radiology

    RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

    FDA 510(k)
    FDA Class 2 ·Radiology

    ART-Plan+ (v.3.0.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARIA Radiation Therapy Management System (18.1)

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

    Other Clearances by Elekta, Inc

    K Number Device Name
    K183034 MOSAIQ Oncology Information System