BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSIGHT MEDICAL SYSTEMS, INC

    Reg #: 3019878658 · FEI: 3019878658 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INSIGHT MEDICAL SYSTEMS, INC
    Registration Number
    3019878658
    FEI Number
    3019878658
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9801 Metric Boulevard
    City
    Austin
    State
    TX
    ZIP
    78758
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243950

    Owner / Operator

    Firm Name
    Kico Knee Innovation Company
    Operator Number
    10054916
    Address
    Unit 1, 25 Frenchs Forest Rd E
    City
    Frenchs Forest
    State
    New South Wales
    Postal Code
    2086
    Country
    AU
    Correspondent
    Danyon Munro

    Products

    Device Name Product Code
    Orthopedic Augmented Reality SBF
    Automated Radiological Image Processing Software QIH
    System, Image Processing, Radiological LLZ

    Proprietary Names

    ARVIS® Shoulder ARVIS Surgical Navigation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility