510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Eizo Corporation

HAKUSAN Ishikawa, JP

EIZO CORPORATION appears in FDA device records in HAKUSAN Ishikawa, JP. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
23
PMA records
0
Recall records
5
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for Eizo Corporation between 2014 and 2025. The busiest year on record is 2016, with 4. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Eizo Corporation, by decision year
YearClearances
20142
20153
20164
20172
20183
20191
20201
20211
20221
20233
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242545RadiForce MX317W-PAPZZSubstantially Equivalent
K243221RadiForce RX570; RadiForce RX570-ARPGYSubstantially Equivalent
K231066CuratOR EX3242-FDGCJSubstantially Equivalent
K230684RadiForce MX217PGYSubstantially Equivalent
K223768RadiForce RX270PGYSubstantially Equivalent
K221136RadiForce MX243WPGYSubstantially Equivalent
K211491RadiForce RX370PGYSubstantially Equivalent
K200485RadiForce RX1270, RadiForce RX1270-ARPGYSubstantially Equivalent
K190153RadiForce MX216PGYSubstantially Equivalent
K182591RadiForce RX360, RX360-ARPGYSubstantially Equivalent
K181609RadiForce GX560, GX560-ARPGYSubstantially Equivalent
K180961RadiForce MX194PGYSubstantially Equivalent
K172738RadiForce RX560, RX560-ARPGYSubstantially Equivalent
K170949RadiForce MX315WPGYSubstantially Equivalent
K1633356MP Color LCD Monitor, RadiForce RX660, RX660-ARPGYSubstantially Equivalent
K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-ARPGYSubstantially Equivalent
K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-ARPGYSubstantially Equivalent
K1533543MP Color LCD Monitor, RadiForce RX350PGYSubstantially Equivalent
K1527138MP Color LCD Monitor, RadiForce RX850, RX850-ARPGYSubstantially Equivalent
K1518835MP Monochrome LCD Monitor, RadiForce GX540PGYSubstantially Equivalent
K1501062MP Color LCD Monitor, RadiForce RS240PGYSubstantially Equivalent
K1432612.3MP Color LCD Monitor, RadiForce MX242WPGYSubstantially Equivalent
K1430983MP Color LCD monitor, RadiForce RS340PGYSubstantially Equivalent

Registered establishments

FDA registered establishments for Eizo Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30002376603000237660EIZO CORPORATION153 SHIMOKASHIWANO, HAKUSAN Ishikawa 924-8566 JP2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2294-2020RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.Under certain conditions, a marble pattern infrequently appears on the monitor.Class IIOpen, Classified
Z-2293-2020RadiForce 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) for review, analysis, and diagnosis by trained medical practitioners.Under certain conditions, a marble pattern infrequently appears on the monitor.Class IIOpen, Classified
Z-2089-2015RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.Class IITerminated
Z-2088-2015RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.Class IITerminated
Z-2087-2015RadiForce 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 mammography for review and analysis by trained medical practitioners.EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain