510(k) Report

FDA applicant

Eizo Corporation

Hakusan, JP34 decisions2008–20264 recalls

FDA records 34 decisions for Eizo Corporation (Hakusan, JP) from 2008 to 2026: 34 510(k) clearances. Most are in product codes PGY (Display, Diagnostic Radiology) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 52 days from receipt to decision, against 53 for FDA’s reviews in the same codes and years. Its devices cite 40 predicates, 24 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Eizo GmbH”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Eizo Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2008: 12011: 22013: 12014: 42015: 32016: 42017: 22018: 32019: 12020: 12021: 12022: 12023: 42024: 22025: 22026 (partial year): 2
2008high 4 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2019

2015: 22019: 2
2008high 2 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Eizo Corporation by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PGYDisplay, Diagnostic Radiology26decisions
  • LLZSystem, Image Processing, Radiological4decisions
  • GCJLaparoscope, General & Plastic Surgery2decisions
  • PZZDigital Pathology Display1decision
  • DXJDisplay, Cathode-Ray Tube, Medical1decision

How long do its 510(k) reviews take?

Since 2016, its 22 510(k)s took a median of 52 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 53 days; 12 of its 22 were faster than that.

Whose devices does it build on?

Its devices cite 40 predicates; 24 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 50 times; 24 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1518835MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 20156cite it
  • K1533543MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 20165cite it
  • K1340026MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 20144cite it
  • K172738RadiForce RX560, RX560-AREizo Corporation · 20174cite it
  • K1602472MP Color LCD Monitor, RadiForce RX250 and RX250-AREizo Corporation · 20163cite it
  • K182591RadiForce RX360, RX360-AREizo Corporation · 20183cite it

What has FDA decided for it lately?

  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K262783RadiForce MX247WEizo Corporation · 2026
  • K252030RadiForce GX570; RadiForce GX570-AREizo Corporation · 2025
  • K242545RadiForce MX317W-PAEizo Corporation · 2025
  • K243221RadiForce RX570; RadiForce RX570-AREizo Corporation · 2024
  • K241441RadiForce RX670; RadiForce RX670-AREizo Corporation · 2024
  • K233465RadiForce MX317WEizo Corporation · 2023
  • K231066CuratOR EX3242-FDEizo Corporation · 2023

All 31 as Eizo Corporation →All 3 as Eizo GmbH →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K181609RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is…Jul 30, 2019Class II
  • K182591RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for…Jul 30, 2019Class II
  • K134002RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC…Jul 7, 2015Class II
  • K140702RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This…Jul 7, 2015Class II

Other applicant names beginning “Eizo”

FDA records each applicant name separately; these may or may not be the same firm.

Eizo Nanao Corporation 34