BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KONICA MINOLTA, INC.

    Reg #: 3003769120 · FEI: 3003769120 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    KONICA MINOLTA, INC.
    Registration Number
    3003769120
    FEI Number
    3003769120
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2970 ISHIKAWA-MACHI
    City
    HACHIOJI-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K212685

    Owner / Operator

    Firm Name
    KONICA MINOLTA, INC.
    Operator Number
    9009884
    Address
    1 Sakura-machi
    City
    Hino-shi
    State
    Tokyo
    Postal Code
    191-8511
    Country
    JP
    Correspondent
    Taketoh Muraoka

    US Agent

    Business Name
    Konica Minolta Healthcare Americas, Inc.
    Contact Name
    Jan Maniscalco
    Address
    411 Newark Pompton Turnpike
    City
    Wayne
    State
    NJ
    ZIP
    07470
    Country
    US
    Email
    [email protected]
    Phone
    800 9341034 ext. 1427

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Full Field Digital, System, X-Ray, Mammographic MUE
    Camera, Multi Format, Radiological LMC
    Instrument, Quality-Assurance, Radiologic LHO

    Proprietary Names

    KONICAMINOLTA DI-X1 CS-7 SKR 3000 REGIUS Plate FP-1S REGIUS Cassette RC-300 REGIUS SIGMA2 REGIUS Cassette/Plate REGIUS Cassette REGIUS Plate REGIUS MODEL 110HQ REGIUS MODEL 110 REGIUS SIGMA AeroDR P-21 AeroDR SYSTEM P-53 AeroSync REGIUS MODEL 210 P-61 Xpress Digital Mammography System AeroDR SYSTEM 2 AeroDR P-51 AeroDR P-31 AeroDR P-12 AeroDR P-11 DRYPRO MODEL 873 P-95 P-82 P-85 P-65 P-75 G-59 G-60 G-22 P-41 SKR 4000 AeroDR P-52 P-81 P-71 Bone Suppression Software Simple Check QC Phantom-2 AeroDR Stitching system

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility