BEUDAMED
    FDA Registration Active 🇨🇳 China

    InferRead CT Lung

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

    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
    K240554

    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
    Automated Radiological Image Processing Software QIH
    Lung Computed Tomography System, Computer-Aided Detection OEB

    Proprietary Names

    InferRead CT Lung InferRead Lung CT.AI

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198