Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030233

FEI Number

3002808139

Entity Name

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

City/State/Country

KYOTO, JP

Establishment Address

1,NISHINOKYO KUWABARA-CHO, NAKAGYO-KU, KYOTO 604-8511, JP

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shimadzu Corporation (Owner Number: 8030233)

Owner / Operator Contact Address

1 NISHINOKYO KUWABARA-CHO, KYOTO-SHI, JP-26 604-8511, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 SHIMADZU X-RAY SYSTEMS Trinias DAR-9000 DAR-7000 DAR-5000 MH-400 MH-200S 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 SHIMADZU X-RAY SYSTEMS RADspeed Pro BR-120T BR-120M BR-120 FLUOROspeed R-20J BK-120MK KS-100 BK-200F KS-70 BK-200 RADIOGRAPHIC TABLE SHIMADZU X-RAY SYSTEMS BRANSIST SAFIRE IA-16L/HS Trinias R-30H R-20J RADspeed fit UD150V-40 UD150L-40 UD150B-40 SHIMADZU X-RAY SYSTEMS UD150L-40E UD150L-40F RADspeed UD 150L-30 UD 150B-30 UD 150L-30FX AUD 150G UD 150L-30EX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2013-01-24
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2013-01-24
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-03-02
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-08-11
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-01-24
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2024-04-22
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2024-04-22
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	2003-01-17
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2003-01-17
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2003-01-17
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-07-19
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2013-01-24
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2013-01-24
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-01-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-24
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2013-01-24
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-01-24
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2003-01-17
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-04-01
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2026-04-01
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2003-01-17
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2003-01-17
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2016-08-08
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	1983-05-27
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-10-17
IZX	Collimator, Manual, Radiographic	Radiology	Class 2	892.1610	2013-01-24
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2003-01-17
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2013-01-24
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-01-24
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-21
IZW	Collimator, Automatic, Radiographic	Radiology	Class 2	892.1610	2003-01-17
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2018-04-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-04-11
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2003-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

Joseph Zegarelli Email: Shimadzu-FDA@shimadzu-usa.com Phone: (310) 2178855

Related Public Records

Same Entity

Shimadzu Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003927316	SHIMANE SHIMADZU CORPORATION	IZUMO Shimane, JP
3001040364	SHIMADZU U.S.A. MANUFACTURING, INC.	Canby, OR, US
3010607747	SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV.	KYOTO, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030233. Last updated year: 2026. Please use registration number 8030233 when referencing this establishment in official correspondence.