BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SYNTHESIS HEALTH INTELLIGENCE INC.

    Reg #: 3032579549 · FEI: 3032579549 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SYNTHESIS HEALTH INTELLIGENCE INC.
    Registration Number
    3032579549
    FEI Number
    3032579549
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    22420 Dewdney Trunk Rd, Suite 300
    City
    Maple Ridge British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K240724

    Owner / Operator

    Firm Name
    Synthesis Health Intelligence Inc.
    Operator Number
    10091358
    Address
    22420 Dewdney Trunk Rd, Suite 300
    City
    Maple Ridge
    State
    British Columbia
    Postal Code
    V2X 3J5
    Country
    CA
    Correspondent
    Amy Gilchrist

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Synthesis "VISION" viewer

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198