Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003927316

FEI Number

3003927316

Entity Name

SHIMANE SHIMADZU CORPORATION

City/State/Country

IZUMO Shimane, JP

Establishment Address

2698 NAOE, HIKAWA-CHO, IZUMO Shimane 699-0631, JP

Establishment Type(s)

Manufacture Medical Device

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

SONIALVISION G4 BK-120MK KS-100 BK-200F KS-70 BK-200 RADIOGRAPHIC TABLE SHIMADZU X-RAY SYSTEMS YSF-300 ZS-100IR REMOTE CONTROLLED DIAGNOSTIC R F TABLE SHIMADZU X-RAY SYSTEMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-03-02
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2003-01-17
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	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
3001040364	SHIMADZU U.S.A. MANUFACTURING, INC.	Canby, OR, US
3010607747	SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV.	KYOTO, JP
8030233	SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION	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

Similar Registrations

Registration Number	Establishment Name	Location
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3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003927316. Last updated year: 2026. Please use registration number 3003927316 when referencing this establishment in official correspondence.