BEUDAMED
    FDA Registration Active 🇺🇸 United States

    X9 INC.

    Reg #: 3042470731 · FEI: 3042470731 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    X9 INC.
    Registration Number
    3042470731
    FEI Number
    3042470731
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Research Pkwy Ste 350
    City
    Wallingford
    State
    CT
    ZIP
    06492
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251673

    Owner / Operator

    Firm Name
    X9 INC.
    Operator Number
    10094633
    Address
    10 Research Parkway, STE 350
    City
    Wallingford
    State
    CT
    Postal Code
    06492
    Country
    US
    Correspondent
    Melissa Viotti

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Ultrasound Imaging For Vascular Access For Hemodialysis SGH
    Automated Radiological Image Processing Software QIH
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    X9 Ultrasound System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device