Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000237660

FEI Number

3000237660

Entity Name

EIZO CORPORATION

City/State/Country

HAKUSAN Ishikawa, JP

Establishment Address

153 SHIMOKASHIWANO, HAKUSAN Ishikawa 924-8566, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EIZO Corporation (Owner Number: 9085040)

Owner / Operator Contact Address

153 Shimokashiwano, Hakusan, JP-17 924-8566, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182591

PMA Number

N/A

All Registered Proprietary Names

1MP Color LCD Monitor, RadiForce MX192 1MP Color LCD Monitor, RadiForce MX192-F EA720-F RadiForce MS236WT-L EA720 RadiForce MS236WT-F RadiForce MX193 RadiForce MX191 RadiForce MX195 RadiForce MS236WT-A 2.3MP Color LCD Monitor, RadiForce MX242W RadiForce MX315W RadiForce RX560-AR RadiForce RX560 EX3140 CuratOR EX2620 CuratOR EX2620-3D (with 3D glasses H3G01 or H3G02) EX2620-3D (with 3D glasses H3G01 or H3G02) EX3141 CuratOR EX2621 EX3220-3D (with 3D glasses H3G01 or H3G02) CuratOR EX3140 EX2721 CuratOR EX3220-3D (with 3D glasses H3G01 or H3G02) CuratOR EX3220 CuratOR EX2721 CuratOR EX3141-3D (with 3D glasses H3G01 or H3G02) TM343 CuratOR EX3241 CuratOR EX3242-3D (with 3D glasses H3G01 or H3G02) CuratOR EX3242 TM344 CuratOR EX2722 TM351 (with 3D glasses H3G01 or H3G02) 8MP Color LCD Monitor, RadiForce RX850-AR 8MP Color LCD Monitor, RadiForce RX850 2MP Monochrome LCD Monitor, RadiForce GX240 3MP Monochrome LCD Monitor, RadiForce GX340 Monochrome LCD Monitor, RadiForce GS220 RadiForce RX570 RadiForce RX570-AR RadiForce MX217 4MP Color LCD Monitor, RadiForce RX440 2MP Color LCD Monitor, RadiForce RX250 2MP Color LCD Monitor, RadiForce RX250-AR RadiForce RX660-AR RadiForce RX660 Color LCD Monitor, RadiForce RS110 RadiForce MX243W RadiForce RX1270 RadiForce RX1270-AR RadiCS CuratOR EX3242-FD 2MP Color LCD Monitor, RadiForce MX215 2MP Color LCD Monitor, RadiForce MX215-X RadiForce GX560 RadiForce GX560-AR RadiForce RX370 RadiForce RX370-AR RadiForce GX570 RadiForce GX570-AR CuratOR MIR-1 3MP Color LCD Monitor, RadiForce RX350-AR 3MP Color LCD Monitor, RadiForce RX350 RadiForce RX360 RadiForce RX360-AR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2014-10-09
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2014-12-11
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-04-27
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-11-08
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2009-08-27
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2015-11-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-05-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-03-26
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-12-11
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-11-28
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-05-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-02-25
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2016-02-24
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-04-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-11-20
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-05-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-03-23
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2024-10-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-12-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-07-23
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2018-08-26
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2021-07-12
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2025-08-31
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2024-08-22
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2016-01-18
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2018-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

THOMAS WALETZKI Business: EIZO Inc. Email: Thomas.waletzki@eizo.com Phone: (562) 4315011

Related Public Records

Same Entity

EIZO Corporation

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number	Establishment Name	Location
3044622440	DICOMSERVER, LLC	Kingwood, TX, US
3043237444	DAIKSO CO., LTD.	Guishan Dist., Taoyuan, TW
3009831823	Trice Imaging, Inc.	Miami, FL, US
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3006619220	Canon Medical Informatics A/S	Valby Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000237660. Last updated year: 2026. Please use registration number 3000237660 when referencing this establishment in official correspondence.