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

    Viz HCM

    K Number: DEN230003 · Decision Aug 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    11
    Review Days
    205

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    Basic Information

    Device Name
    Viz HCM
    K Number
    DEN230003
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.2380
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Viz. Ai, Inc.
    Date Received
    January 10, 2023
    Decision Date
    August 3, 2023
    Product Code
    QXO
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QXO Cardiovascular Machine Learning-Based Notification Software

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    Other Clearances by Viz. Ai, Inc.

    K Number Device Name
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    K223042 Viz LVO ContaCT
    K221100 Viz RV/LV
    K220439 Viz SDH
    K213319 Viz ANEURYSM, Viz ANX
    K210209 Viz ICH
    K193658 Viz ICH
    K180161 Viz CTP
    Search all 11 clearances from Viz. Ai, Inc. →