BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    ARTRYA

    Reg #: 3017233423 · FEI: 3017233423 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    3

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    Registration Details

    Registration Name
    ARTRYA
    Registration Number
    3017233423
    FEI Number
    3017233423
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1257 Hay St, West Perth WA 6005
    City
    Perth Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K251837

    Owner / Operator

    Firm Name
    Artrya
    Operator Number
    10089524
    Address
    1257 Hay St, West Perth WA 6005
    City
    Perth
    State
    Western Australia
    Postal Code
    6005
    Country
    AU
    Correspondent
    Gabriela Quijada

    US Agent

    Business Name
    Artrya USA Inc
    Contact Name
    Richard Stewart
    Address
    1230 Rosecrans Ave Ste 300
    City
    Manhattan Beach
    State
    CA
    ZIP
    90266
    Country
    US
    Email
    [email protected]
    Phone
    213 7521516

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Automated Radiological Image Processing Software QIH
    Medical Device Data System OUG

    Proprietary Names

    Salix Coronary Plaque System for CCTA Image Data Salix® Coronary Anatomy

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device