BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

    Reg #: 8030233 · FEI: 3002808139 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    99
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Registration Number
    8030233
    FEI Number
    3002808139
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1,NISHINOKYO KUWABARA-CHO, NAKAGYO-KU
    City
    KYOTO
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K101039

    Owner / Operator

    Firm Name
    Shimadzu Corporation
    Operator Number
    8030233
    Address
    1 NISHINOKYO KUWABARA-CHO
    City
    KYOTO-SHI
    State
    JP-26
    Postal Code
    604-8511
    Country
    JP

    Products

    Device Name Product Code
    Collimator, Manual, Radiographic IZX
    Collimator, Automatic, Radiographic IZW
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, X-Ray, Angiographic IZI
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    Tube Mount, X-Ray, Diagnostic IYB
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    System, Tomography, Computed, Emission KPS
    System, Image Processing, Radiological LLZ
    System, X-Ray, Mobile IZL
    Table, Radiographic, Tilting IXR
    Automated Radiological Image Processing Software QIH
    Interventional Fluoroscopic X-Ray System OWB
    Assembly, Tube Housing, X-Ray, Diagnostic ITY
    Holder, Radiographic Cassette, Wall-Mounted IXY
    Table, Radiographic, Stationary Top IXQ
    Generator, High-Voltage, X-Ray, Diagnostic IZO

    Proprietary Names

    R-300 SONIALVISION G4 IA-16LM(6)/HS IA-12LT13 IA-12LT/HS13 IA-12LT/HS IA-16LT/HS13 IA-16LT/HS IA-16LM/HS IA-12LM IA-16LD/HS IA-12LM13 IA-16LM/HS13 IA-12LT IA-12LD IA-12LD13 IA-16LD/HS13 IA-12LD/HS13 IA-12LD/HS IA-16LD/HS12 IA-16LM(6)/HS12 IA-16LM(6)/HS13 IA-16LM/HS12 DAR-8000F FDR Visionary Suite FH-20HR FH-21HR CH-200 CH-200M DIAGNOSTIC X-RAY TUBE MOUNT SHIMADZU X-RAY SYSTEMS DAR-5000 DAR-7000 MH-400 DAR-9000 MH-200S WHA-200 PositView SET-5002 R-30H DAR-8000I FDR Go MOBILEDART EVOLUTION RADSPEED SAFIRE YSF-300 ZS-100IR REMOTE CONTROLLED DIAGNOSTIC R F TABLE Trinias 0.7/1.3U163C-36 0.6/1J327C-280 0.6/1.2P324DK-85 0.6/1.2P364DK-125 0.6/1J327C-280AYS 0.6/1.2P364DK-85 0.7/1.2JG326D-265 0.6/1.2P324DK-125 0.6/1J327C-282AX 0.7U163CS-36 1/2P18DK-85 0.6/1.2P18DE-85 0.6/1.2P13DK-85 1/2P13DK-85 0.4/0.7JG326D-265 0.6/1.2P326D-150 0.6/1.2P366D-150 J317C-282AX 0.6/1J327C-280AX ,0.6 0.4/0.7JG326D-265AX RADspeed Pro BR-120T BR-120M BR-120 FLUOROspeed R-20J BK-120MK KS-100 BK-200F KS-70 BK-200 RADIOGRAPHIC TABLE BRANSIST SAFIRE IA-16L/HS RADspeed fit UD150V-40 UD150L-40 UD150B-40 UD150L-40E UD150L-40F RADspeed UD 150L-30 UD 150B-30 UD 150L-30FX AUD 150G UD 150L-30EX MUX-100D DAR-9400F MOBILEART EVOLUTION

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)