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

    CORVUS RADIATION THERAPY PLANNING SYSTEM

    K Number: K100092 · Decision Feb 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    255
    Applicant Total
    5
    Review Days
    41

    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
    CORVUS RADIATION THERAPY PLANNING SYSTEM
    K Number
    K100092
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Best Nomos
    Date Received
    January 13, 2010
    Decision Date
    February 23, 2010
    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 Best Nomos

    K Number Device Name
    K211034 Corvus Radiation Therapy Planning System
    K201350 CORVUS
    K170345 SOFTDISO
    K151469 CORVUS Radiation Therapy Planning System