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Data / Medical devices / Japan / Shimadzu Corporation Medical Systems Division

Shimadzu Corporation Medical Systems Division: FDA-registered device maker in Kyoto, Japan, 31 510(k) clearances

Shimadzu Corporation Medical Systems Division is registered with the FDA (registration 8030233) in Kyoto, Japan. It lists 18 device types. The FDA files 31 510(k) clearances under its listings, the newest dated March 24, 2026. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Shimadzu Corporation Medical Systems Division
FDA registration number
8030233
FEI number
3002808139
Address
1,nishinokyo Kuwabara-Cho Nakagyo-Ku, Kyoto, Japan, 604-8511
Owner or operator
Shimadzu Corporation (8030233)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer
First device listed
May 27, 1983
Registered through
2026
Brand names listed
,0.6, 0.4/0.7JG326D-265, 0.4/0.7JG326D-265AX, 0.6/1.2P13DK-85, 0.6/1.2P18DE-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P326D-150 and more

Devices it lists

DeviceProduct codeClassRoleSource
Assembly, Tube Housing, X-Ray, DiagnosticITY1Contract manufacturer, Manufactureraccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Complaint file establishment, Manufactureraccessdata.fda.gov
Collimator, Automatic, RadiographicIZW2Manufactureraccessdata.fda.gov
Collimator, Manual, RadiographicIZX2Manufactureraccessdata.fda.gov
Generator, High-Voltage, X-Ray, DiagnosticIZO1Contract manufacturer, Manufactureraccessdata.fda.gov
Holder, Radiographic Cassette, Wall-MountedIXY1Complaint file establishment, Manufactureraccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Complaint file establishment, Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
System, Tomography, Computed, EmissionKPS2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, AngiographicIZI2Contract manufacturer, Manufactureraccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, MobileIZL2Manufactureraccessdata.fda.gov
System, X-Ray, StationaryKPR2Complaint file establishment, Manufactureraccessdata.fda.gov
Table, Radiographic, Stationary TopIXQ2Manufactureraccessdata.fda.gov
Table, Radiographic, TiltingIXR2Manufactureraccessdata.fda.gov
Tube Mount, X-Ray, DiagnosticIYB1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 24, 2026K252099TriniasOWBSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
May 24, 2024K240827SET-5002KPSSubstantially EquivalentShimadzu Corporation Medical Systems Divisionaccessdata.fda.gov
March 28, 2024K233719FDR Visionary SuiteKPRSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
February 23, 2024K233722RADspeed ProKPRSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
July 28, 2022K221922TriniasOWBSubstantially EquivalentShimadzu Corporation Medical Systems Divisionaccessdata.fda.gov
April 28, 2021K203535TriniasOWBSubstantially EquivalentShimadzu Corporation Medical Systemsaccessdata.fda.gov
August 5, 2019K191877FLUOROspeedJAASubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
March 30, 2018K173517RADspeed fitKPRSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
July 15, 2016K152294FDR Visionary SuiteKPRSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
June 20, 2016K152244RADspeed ProKPRSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
March 6, 2015K142341X-RAY TV SYSTEM SONIALVISION G4JAASubstantially EquivalentShimadzu Corp.accessdata.fda.gov
March 28, 2014K131075X-RAY TV SYSTEM SONIAL VISION G4JAASubstantially EquivalentShimadzu Corp.accessdata.fda.gov
February 26, 2014K123508TRINIASOWBSubstantially EquivalentShimadzu Corporationaccessdata.fda.gov
September 20, 2010K101039SHIMADZU COLLIMATOR R-300IZWSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
August 26, 2010K101036SHIMADZU COLLIMATOR R-20JIZXSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
November 6, 2009K090578SHIMADZU COLLIMATOR R-30HIZWSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
June 30, 2009K090268SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTIONIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
May 14, 2008K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
August 31, 2007K072006DAR-9400FIZISubstantially EquivalentShimadzu Corp.accessdata.fda.gov
October 5, 2006K062360BRANSIST SAFIREIZISubstantially EquivalentShimadzu Corp.accessdata.fda.gov
October 17, 2005K052500DAR-8000FIZISubstantially EquivalentShimadzu Medical Systemsaccessdata.fda.gov
September 2, 2005K052076DAR-8000IIZISubstantially EquivalentShimadzu Medical Systemsaccessdata.fda.gov
June 1, 2005K050925DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIREMQBSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
February 17, 2005K043379SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200OXOSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
July 13, 2004K041763SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIESIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
May 17, 2004K040870SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HSJAASubstantially EquivalentShimadzu Corp.accessdata.fda.gov
February 20, 2004K032443DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIREIZISubstantially EquivalentShimadzu Corp.accessdata.fda.gov
December 9, 2003K033184LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400IZISubstantially EquivalentShimadzu Corp.accessdata.fda.gov
October 18, 2001K012424SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LMJAASubstantially EquivalentShimadzu Corp.accessdata.fda.gov
February 3, 1995K943545CEILING SUSPENDED C-ARM SUPPORT MH-100IZISubstantially EquivalentShimadzu Medical Systemsaccessdata.fda.gov
April 16, 1992K920725COLLIMATOR F-20IZWSubstantially EquivalentShimadzu Medical Systemsaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 16, 202597365Class IIOngoingCeiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed, SonialVision and FLUOROspeed Systems The ceiling type x-ray tube support CH-200 is used to hold the X-ray tube and collimator to position the Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.accessdata.fda.gov
September 6, 202495450Class IIOngoingSONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.accessdata.fda.gov
September 6, 202495406Class IIOngoingTrinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generaIf digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.accessdata.fda.gov
January 29, 202493933Class IIOngoingShimadzu, Trinias, Digital Angiography SystemDue to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.accessdata.fda.gov
April 10, 202392391Class IIOngoingOver-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 unitsEight fixing bolts at the base of the X-ray ceiling tube column assembly may be loose or missing so service is required to install a cable, bracket, and label behind the bracket, indicating when service is required, to eliminate the risk of the device falling.accessdata.fda.gov

Compare with other makers

Updated March 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.