BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Viz.ai Israel Ltd

    Reg #: 3014665798 · FEI: 3014665798 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    Viz.ai Israel Ltd
    Registration Number
    3014665798
    FEI Number
    3014665798
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 Menachem Begin
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K180161

    Owner / Operator

    Firm Name
    Viz.ai, Inc.
    Operator Number
    10057967
    Address
    548 Market St #21826
    City
    San Francisco
    State
    CA
    Postal Code
    94104
    Country
    US

    US Agent

    Business Name
    VIZ.AI, INC.
    Contact Name
    Gregory Ramina
    Address
    5000 Center Green Way
    City
    Cary
    State
    NC
    ZIP
    27513
    Country
    US
    Email
    [email protected]
    Phone
    415 6636130

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Radiological Computer-Assisted Triage And Notification Software QAS
    Cardiovascular Machine Learning-Based Notification Software QXO
    Radiological Computer-Assisted Prioritization Software For Lesions QFM

    Proprietary Names

    Viz CTP Viz SDH Measurements Viz SDH Collections Viz Subdural+ Viz Subdural Measurements Viz SDH Plus Viz Subdural Plus Viz Subdural Collections Viz SDH+ Viz SDH Viz SUBDURAL Viz ICH Viz HDS Viz VOLUME PLUS Viz ICH PLUS Viz ICH+ Viz HCM Viz ANEURYSM Viz ANX Viz AAA Viz LVO Viz RV/LV

    Establishment Types

    Manufacture Medical Device