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Data / Medical devices / Japan / Eizo Corporation

Eizo Corporation: FDA-registered device maker in HAKUSAN Ishikawa, Japan, 29 510(k) clearances

Eizo Corporation is registered with the FDA (registration 3000237660) in HAKUSAN Ishikawa, Japan. It lists 8 device types. The FDA files 29 510(k) clearances under its listings, the newest dated September 11, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Eizo Corporation
FDA registration number
3000237660
Address
153 Shimokashiwano, HAKUSAN Ishikawa, Japan, 924-8566
Owner or operator
EIZO Corporation (9085040)
Roles
Manufacturer, Specification developer
First device listed
August 27, 2009
Registered through
2027
Brand names listed
1MP Color LCD Monitor, RadiForce MX192, 1MP Color LCD Monitor, RadiForce MX192-F, 2.3MP Color LCD Monitor, RadiForce MX242W, 2MP Color LCD Monitor, RadiForce MX215, 2MP Color LCD Monitor, RadiForce MX215-X, 2MP Color LCD Monitor, RadiForce RX250, 2MP Color LCD Monitor, RadiForce RX250-AR, 2MP Monochrome LCD Monitor, RadiForce GX240 and more

Devices it lists

DeviceProduct codeClassRoleSource
Camera, Surgical And AccessoriesKQM1Manufacturer, Specification developeraccessdata.fda.gov
Device, Digital Image Storage, RadiologicalLMB1Manufactureraccessdata.fda.gov
Digital Pathology DisplayPZZ2Manufactureraccessdata.fda.gov
Display, Diagnostic RadiologyPGY2Manufactureraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
System, Digital Image Communications, RadiologicalLMD1Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.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
September 11, 2026K262397CuratOR EX2742GCJSubstantially EquivalentEizo Corporationaccessdata.fda.gov
September 1, 2026K262783RadiForce MX247WPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
August 28, 2025K252030RadiForce GX570; RadiForce GX570-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
May 23, 2025K242545RadiForce MX317W-PAPZZSubstantially EquivalentEizo Corporationaccessdata.fda.gov
November 27, 2024K243221RadiForce RX570; RadiForce RX570-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
July 16, 2024K241441RadiForce RX670; RadiForce RX670-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
December 21, 2023K233465RadiForce MX317WPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
December 18, 2023K231066CuratOR EX3242-FDGCJSubstantially EquivalentEizo Corporationaccessdata.fda.gov
May 12, 2023K230684RadiForce MX217PGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
April 20, 2023K223768RadiForce RX270PGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
May 10, 2022K221136RadiForce MX243WPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
July 12, 2021K211491RadiForce RX370PGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
March 23, 2020K200485RadiForce RX1270, RadiForce RX1270-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
March 8, 2019K190153RadiForce MX216PGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
October 18, 2018K182591RadiForce RX360, RX360-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
August 24, 2018K181609RadiForce GX560, GX560-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
May 10, 2018K180961RadiForce MX194PGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
November 8, 2017K172738RadiForce RX560, RX560-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
April 27, 2017K170949RadiForce MX315WPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
December 15, 2016K1633356MP Color LCD Monitor, RadiForce RX660, RX660-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
September 19, 2016K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
February 23, 2016K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
January 12, 2016K1533543MP Color LCD Monitor, RadiForce RX350PGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
November 20, 2015K1527138MP Color LCD Monitor, RadiForce RX850, RX850-ARPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
November 21, 2014K1432612.3MP Color LCD Monitor, RadiForce MX242WPGYSubstantially EquivalentEizo Corporationaccessdata.fda.gov
July 3, 2013K1310902MP COLOR LCD MONITOR, RADIFORCE MX215LLZSubstantially EquivalentEizo Corporationaccessdata.fda.gov
February 8, 2013K1300704MP COLOR LCD MONITOR, RADIFORCE RX440LLZSubstantially EquivalentEizo Nanao Corporationaccessdata.fda.gov
April 19, 2012K1204072MP MONOCHROME LCD MONITOR, RADIFORCE GX240LLZSubstantially EquivalentEizo Nanao Corporationaccessdata.fda.gov
March 2, 2012K1137843MP MONOCHROME LCD MONITOR, RADIFORCE GX340LLZSubstantially EquivalentEizo Nanao Corporationaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
July 30, 201985299Class IIOngoingRadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) forUnder certain conditions, a marble pattern infrequently appears on the monitor.accessdata.fda.gov
July 7, 201571628Class IITerminatedRadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mamEIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.accessdata.fda.gov

Compare with other makers

Updated September 11, 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.