BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TAU Model 1000-0017 Mini C-Arm

    Reg #: 3005254598 · FEI: 3005254598 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    ORTHOSCAN, INC.
    Registration Number
    3005254598
    FEI Number
    3005254598
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14555 N. 82nd Street
    City
    SCOTTSDALE
    State
    AZ
    ZIP
    85260
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183220

    Owner / Operator

    Firm Name
    Ziehm-Orthoscan INC.
    Operator Number
    9073005
    Address
    14555 N. 82nd Street
    City
    Scottsdale
    State
    AZ
    Postal Code
    85260
    Country
    US

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA

    Proprietary Names

    TAU Model 1000-0017 Mini C-Arm TAU Model 1000-0016 Mini C-Arm TAU Model 1000-0015 Mini C-Arm

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device