BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    KONICA MINOLTA, INC.

    Reg #: 3004485675 · FEI: 3004485675 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    76
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    KONICA MINOLTA, INC.
    Registration Number
    3004485675
    FEI Number
    3004485675
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1 SAKURA-MACHI
    City
    HINO-SHI Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K141271

    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, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, X-Ray, Stationary KPR
    Full Field Digital, System, X-Ray, Mammographic MUE
    Camera, Multi Format, Radiological LMC
    Instrument, Quality-Assurance, Radiologic LHO
    Film, Radiographic IWZ

    Proprietary Names

    AeroDR SYSTEM 2 AeroDR P-51 CS-7 SKR 3000 P-81 P-71 Ultrasound System SONIMAGE HS1 Sector Probe S4-2 Convex Probe C5-2 Linear Probe L18-4 AeroDR P-21 AeroDR SYSTEM REGIUS Plate REGIUS Cassette REGIUS Cassette/Plate REGIUS MODEL 210 AeroDR S30 AeroDR S33 AeroDR T50 AeroDR X70 Ceiling Suspension (0170CS) AeroDR X70 KONICAMINOLTA DI-X1 Linear Probe L14-4 Convex Probe MC10-3 Linear Probe HL18-4 Ultrasound System SONIMAGE MX1 Linear Probe L11-3 Bone Suppression Software Xpress Digital Mammography System P-61 DRYPRO TH AeroDR P-12 AeroDR P-11 Simple Check QC Phantom-2 DRYPRO MODEL 873 AeroSync DRYPRO MODEL 832 P-65 P-75 G-59 G-60 G-22 REGIUS Plate FP-1S REGIUS Cassette RC-300 REGIUS SIGMA2 AeroDR Stitching system AeroDR P-31 ImagePilot P-53 P-41 SKR 4000 Endocavity Probe EC9-3 Ultrasound System SONIMAGE HS2 REGIUS SIGMA P-95 P-82 P-85 MEDICAL IMAGING FILM SD-QM2 MEDICAL IMAGING FILM SD-PC X-RAY FILM MG-SR PLUS MEDICAL IMAGING FILM SR-IC PLUS MEDICAL IMAGING FILM SD-P MEDICAL IMAGING FILM SD-QM MEDICAL IMAGING FILM SD-Q X-RAY FILM CM-H2 for MAMMOGRAPHY MEDICAL IMAGING FILM SD-S MEDICAL IMAGING FILM SD-PM MEDICAL DUPLICATING FILM SR-DUP PLUS MEDICAL IMAGING FILM SD-E MEDICAL IMAGING FILM SD-Q2 MEDICAL IMAGING FILM TR-S REGIUS MODEL 110HQ REGIUS MODEL 110 Xpress Digital Mammography workstation ACIES AeroDR P-52

    Establishment Types

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