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

    ONCENTRA BRACHY

    K Number: K132816 · Decision Jun 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    51
    Same Product Code
    243
    Applicant Total
    6
    Review Days
    277

    Basic Information

    Device Name
    ONCENTRA BRACHY
    K Number
    K132816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NUCLETRON B.V.
    Date Received
    September 9, 2013
    Decision Date
    June 13, 2014
    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 NUCLETRON B.V.

    K Number Device Name
    K151272 Henschke Titanium Applicator Set
    K140803 LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
    K132889 FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
    K132874 LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
    K132092 ESTEYA