BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ONYX-RAD TELEMEDICINE PACS

    Reg #: 1064396 · FEI: 3002885429 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Konica Minolta Healthcare Americas, Inc
    Registration Number
    1064396
    FEI Number
    3002885429
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2217 Us Highway 70 E
    City
    Garner
    State
    NC
    ZIP
    27529
    Country
    US

    Regulatory Submissions

    510(k) Number
    K003607

    Owner / Operator

    Firm Name
    Konica Minolta Healthcare Americas, Inc.
    Operator Number
    2241281
    Address
    411 NEWARK-POMPTON TURNPIKE, --
    City
    Wayne
    State
    NJ
    Postal Code
    07470
    Country
    US
    Correspondent
    Jan Maniscalco

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    ONYX-RAD TELEMEDICINE PACS

    Establishment Types

    Manufacture Medical Device