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
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    11
    Review Days
    91

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    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

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    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
    K223443 Viz AAA
    K223042 Viz LVO ContaCT
    K221100 Viz RV/LV
    K220439 Viz SDH
    K213319 Viz ANEURYSM, Viz ANX
    K210209 Viz ICH
    K193658 Viz ICH
    Search all 11 clearances from Viz. Ai, Inc. →