BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    RADIFY Triage

    Reg #: 3030491946 · FEI: 3030491946 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ENVISIONIT DEEP AI Ltd
    Registration Number
    3030491946
    FEI Number
    3030491946
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Coveham House, Downside Bridge Road, Cobham, KT11 3 EP, United Kingdom
    City
    Cobham Surrey
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K231871

    Owner / Operator

    Firm Name
    Envisionit Deep AI
    Operator Number
    10090083
    Address
    Coveham House, Downside Bridge Road, Cobham, KT11 3 EP, United Kingdom
    City
    Cobham
    State
    Surrey
    Postal Code
    KT11 3 EP
    Country
    GB
    Correspondent
    Bhavta Nundkoomar

    US Agent

    Business Name
    Medical Device Academy Incorporated
    Contact Name
    Robert Packard
    Address
    345 Lincoln Hill Rd
    City
    Cuttingsville
    State
    VT
    ZIP
    05738
    Country
    US
    Email
    [email protected]
    Phone
    802 2581881

    Products

    Device Name Product Code
    Radiological Computer-Assisted Prioritization Software For Lesions QFM

    Proprietary Names

    RADIFY Triage

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device