BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Konica Minolta Healthcare Americas, Inc

    Reg #: 1064396 · FEI: 3002885429 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Konica Minolta Healthcare Americas, Inc
    Registration Number
    1064396
    FEI Number
    3002885429
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2217 Us Highway 70 E
    City
    Garner
    State
    NC
    ZIP
    27529
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063337

    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
    System, X-Ray, Stationary KPR
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    OPAL-RAD OTC DDR ONYX-RAD TELEMEDICINE PACS ViZion DR + Wireless VIZION DR VIZTEK WL Straight Arm DDR KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography VIZTEK DR, MODELS: DR1000, DR3000, DR4000 VIZION + DR EXA or Symmetry PACS VIZION ULTRA

    Establishment Types

    Manufacture Medical Device