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

    Viz CTP

    K Number: K180161 · Decision Apr 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    10
    Review Days
    91

    Basic Information

    Device Name
    Viz CTP
    K Number
    K180161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Viz.ai, Inc.
    Date Received
    January 19, 2018
    Decision Date
    April 20, 2018
    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 Viz.ai, Inc.

    K Number Device Name
    K250354 Viz Subdural+, Viz SUBDURAL PLUS
    K232363 Viz HDS, Viz Volume Plus, Viz ICH+
    DEN230003 Viz HCM
    K223042 Viz LVO ContaCT
    K221100 Viz RV/LV
    K220439 Viz SDH
    K213319 Viz ANEURYSM, Viz ANX
    K210209 Viz ICH
    K193658 Viz ICH