BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDLINK IMAGING, LLC.

    Reg #: 2433615 · FEI: 2433615 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    MEDLINK IMAGING, LLC.
    Registration Number
    2433615
    FEI Number
    2433615
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1 CHAPIN RD STE 3
    City
    Pine Brook
    State
    NJ
    ZIP
    07058
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221512

    Owner / Operator

    Firm Name
    MEDLINK IMAGING
    Operator Number
    2433615
    Address
    1 CHAPIN ROAD, UNIT 3, --
    City
    Pine Brook
    State
    NJ
    Postal Code
    07058
    Country
    US
    Correspondent
    Brandon Cho

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Mobile IZL
    System, X-Ray, Stationary KPR
    System, Image Processing, Radiological LLZ
    Full Field Digital, System, X-Ray, Mammographic MUE
    Film, Radiographic IWZ

    Proprietary Names

    VIVIX-S DR FW Series 4343 FAW Wireless Panel, VIVIX-S DR FW Series 4343 FAW-PLUS Wireless Panel VIVIX-S DR FW Series 2530 FAW Wireless Panel, VIVIX-S DR FW Series 2530 FAW-PLUS Wireless Panel VIVIX-S DR FW Series 3643 FAW Wireless Panel, VIVIX-S DR FW Series 3643 FAW-PLUS Wireless Panel VIVIX-S DR 1717N Cassette Size Tethered Panel VIVIX-S DR 1717N Cassette Size Wireless Panel VIVIX-S 1751S VIVIX-S DR 1012N Wireless Panel VIVIX-S DR Panel Medlink Rover Medlink FDR, Medlink FDR-PLUS, Medlink SDR, Medlink SDR-PLUS, Medlink CDR VIVIX-S DR VW Series 1417VW-PLUS Wireless Panel VIVIX-S DR VW Series 1012VW-PLUS Wireless Panel VIVIX-S DR VW Series Wireless Panel VIVIX-S DR VW Series 1717VW Wireless Panel VIVIX-S DR VW Series 1417VW Wireless Panel VIVIX-S DR VW Series 1717VW-PLUS Wireless Panel VIVIX-S DR VW Series 1012VW Wireless Panel QXLink VIVIX-M Medlink M1 Mobile X-Ray System Medlink JADE Mobile Solution Medlink JADE Portable X-Ray System VIVIX-S DR 1417S Tethered Panel VIVIX-S DR 1717V Fixed Panel !M1 Medlink FC RAD ROOM Medlink FM STANDARD RAD ROOM Medlink FM PREMIUM RAD ROOM VIVIX-S 4386W VIVIX-S DR 1417N Wireless Panel

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198