BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    FUJITA CO., LTD.

    Reg #: 3036666444 · FEI: 3036666444 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    FUJITA CO., LTD.
    Registration Number
    3036666444
    FEI Number
    3036666444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5-1-1 Koujimachi
    City
    Chiyoda-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K120579
    PMA Number
    P080003

    Owner / Operator

    Firm Name
    FUJITA CO., LTD.
    Operator Number
    10092556
    Address
    5-1-1 Koujimachi
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    1020083
    Country
    JP
    Correspondent
    Tetsuya Hara

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, X-Ray, Angiographic IZI
    System, Tomography, Computed, Emission KPS
    Densitometer, Bone KGI
    Digital Breast Tomosynthesis OTE
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Interventional Fluoroscopic X-Ray System OWB
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Coil, Magnetic Resonance, Specialty MOS
    System, Nuclear Magnetic Resonance Imaging LNH
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Assembly, Tube Housing, X-Ray, Diagnostic ITY

    Proprietary Names

    Siemens Somatom Definition Edge Philips Allura XPER FD20/10 Philips Allura XPER FD20 Philips Allura XPER FD20/15 Philips Allura XPER FD20/20 GE Discovery NM 830 GE Lunar Prodigy Bone Densitometer Hologic Dimensions 3D Mammography GE DPX Bravo Bone Densitometer GE Innova IGS Cath Angio GE Discovery PET/CT 690 GE 1.5T Signa HDXT MR Siemens Magnetom Aera MRI Medtronic O-Arm Siemens Somatom Sensation CT Siemens Biograph 16 TruePoint PET/CT Hologic Horizon Bone Densitometer Siemens Magnetom Project 047 Siemens Magnetom Avanto Fit Philips Achieva 1.5T Siemens Magnetom Essenza MRI GE Signa Excite 1.5T Siemens Straton tube Philips Ingenia 1.5T MRI Siemens Artis Zee

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device