BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VIZ.AI, INC.

    Reg #: 3014678441 · FEI: 3014678441 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    22
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    VIZ.AI, INC.
    Registration Number
    3014678441
    FEI Number
    3014678441
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5000 Center Green Way
    City
    Cary
    State
    NC
    ZIP
    27513
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210209

    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
    Correspondent
    Gregory M Ramina

    Products

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

    Proprietary Names

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

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198