BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Quantib AI Node

    K Number: K200899 · Decision Jun 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    7
    Review Days
    73

    Basic Information

    Device Name
    Quantib AI Node
    K Number
    K200899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantib BV
    Date Received
    April 3, 2020
    Decision Date
    June 15, 2020
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

    Similar 510(k) Clearances

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

    CustomSurg OrthoPlanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    uOmniscan

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mosaic (V1.0.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    UroNav 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    TechLive

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMARTDent

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

    Other Clearances by Quantib BV

    K Number Device Name
    K230772 Quantib Prostate
    K221106 Quantib Prostate
    K202501 Quantib Prostate
    K182564 Quantib ND
    K173939 Quantib Brain
    K163013 Quantib Brain 1.2