BEUDAMED
    FDA Registration Active 🇨🇳 China

    InferRead CT Stroke.AI

    Reg #: 3017936680 · FEI: 3017936680 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Infervision Medical Technology Co., Ltd.
    Registration Number
    3017936680
    FEI Number
    3017936680
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room B401, 4th Floor, Building 1, No.12 Shangdi Information Road, Haidian District
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K211179

    Owner / Operator

    Firm Name
    Infervision US Inc
    Operator Number
    10079796
    Address
    1099 Wall Street West, Suite 352
    City
    Lyndhurst
    State
    NJ
    Postal Code
    07071
    Country
    US
    Correspondent
    Matt Deng

    Products

    Device Name Product Code
    Radiological Computer-Assisted Triage And Notification Software QAS

    Proprietary Names

    InferRead CT Stroke.AI

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device