BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Limbus Contour

    K Number: K241837 · Decision Oct 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    45
    Applicant Total
    3
    Review Days
    106

    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
    Limbus Contour
    K Number
    K241837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Limbus Ai, Inc.
    Date Received
    June 25, 2024
    Decision Date
    October 9, 2024
    Product Code
    QKB
    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
    QKB Radiological Image Processing Software For Radiation Therapy

    Similar 510(k) Clearances

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

    DeepBT Detector-Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    AI-Rad Companion Organs RT

    FDA 510(k)
    FDA Class 2 ·Radiology

    Contour ProtégéAI+

    FDA 510(k)
    FDA Class 2 ·Radiology

    AutoContour (RADAC V5)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Seg Pro V3 (RT-300)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AccuContour 4.0

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

    Other Clearances by Limbus Ai, Inc.

    K Number Device Name
    K230575 Limbus Contour
    K201232 Limbus Contour