BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARVIS® Shoulder

    Reg #: 3019878658 · FEI: 3019878658 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INSIGHT MEDICAL SYSTEMS, INC
    Registration Number
    3019878658
    FEI Number
    3019878658
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9801 Metric Boulevard
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240062

    Owner / Operator

    Firm Name
    Insight Medical Systems, Inc
    Operator Number
    10082416
    Address
    9801 Metric Blvd
    City
    Austin
    State
    TX
    Postal Code
    78758
    Country
    US
    Correspondent
    Jennifer Anderson

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Orthopedic Stereotaxic Instrument OLO
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    ARVIS® Shoulder

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)