BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Site-Rite® 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Technology

    Reg #: 3009756153 · FEI: 3009756153 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ZIEN MEDICAL TECHNOLOGIES INC
    Registration Number
    3009756153
    FEI Number
    3009756153
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2490 South 300 West
    City
    Salt Lake City
    State
    UT
    ZIP
    84115
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182281

    Owner / Operator

    Firm Name
    Zien Medical Technologies Inc
    Operator Number
    10047676
    Address
    2757South 300West, Suite F
    City
    Salt Lake City
    State
    UT
    Postal Code
    84115
    Country
    US
    Correspondent
    Tim Nieman

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Image Processing, Radiological LLZ

    Proprietary Names

    Site-Rite® 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Technology

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)