BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARTERA

    Reg #: 3029787717 · FEI: 3029787717 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ARTERA
    Registration Number
    3029787717
    FEI Number
    3029787717
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    108 1st St
    City
    Los Altos
    State
    CA
    ZIP
    94022
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240068

    Owner / Operator

    Firm Name
    Artera
    Operator Number
    10093385
    Address
    108 1st Street
    City
    Los Altos
    State
    CA
    Postal Code
    94022
    Country
    US
    Correspondent
    Candice Bautista

    Products

    Device Name Product Code
    Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis SFH
    Software Algorithm Device To Assist Users In Digital Pathology QPN

    Proprietary Names

    ArteraAI Prostate

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only