Eizo Corporation: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Eizo Corporation” (first 2013, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 51 days. Since 2017 the median was 57 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 76 |
| 2014 | 4 | 18 |
| 2015 | 3 | 60 |
| 2016 | 4 | 20 |
| 2017 | 2 | 42 |
| 2018 | 3 | 28 |
| 2019 | 1 | 37 |
| 2020 | 1 | 25 |
| 2021 | 1 | 60 |
| 2022 | 1 | 21 |
| 2023 | 4 | 93 |
| 2024 | 2 | 53 |
| 2025 | 2 | 164 |
| 2026 | 2 | 42 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eizo Corporation took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PGY | Display, Diagnostic Radiology | 26 | 26 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
| PZZ | Digital Pathology Display | 1 | 1 |
Review panels
- Radiology (28)
- General and Plastic Surgery (2)
- Pathology (1)
Most recent Eizo Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262397 | CuratOR EX2742 | GCJ | 2026-09-11 | 59 |
| K262783 | RadiForce MX247W | PGY | 2026-09-01 | 26 |
| K252030 | RadiForce GX570; RadiForce GX570-AR | PGY | 2025-08-28 | 59 |
| K242545 | RadiForce MX317W-PA | PZZ | 2025-05-23 | 269 |
| K243221 | RadiForce RX570; RadiForce RX570-AR | PGY | 2024-11-27 | 51 |
| K241441 | RadiForce RX670; RadiForce RX670-AR | PGY | 2024-07-16 | 55 |
| K233465 | RadiForce MX317W | PGY | 2023-12-21 | 58 |
| K231066 | CuratOR EX3242-FD | GCJ | 2023-12-18 | 248 |
| K230684 | RadiForce MX217 | PGY | 2023-05-12 | 60 |
| K223768 | RadiForce RX270 | PGY | 2023-04-20 | 126 |
21 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-07-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Eizo Nanao Corporation (34 510(k)s)
- Eizo GmbH (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eizo Corporation?
FDA lists 31 510(k) clearances under the applicant name “Eizo Corporation” (first 2013, latest 2026), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eizo Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eizo Corporation is 51 days. Since 2017: 57 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eizo Corporation?
The most frequent FDA product codes under this applicant name are PGY (Display, Diagnostic Radiology, 26); GCJ (Laparoscope, General & Plastic Surgery, 2); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 31 Eizo Corporation clearances with predicates and recalls
- Run predicate analysis for product code PGY, Eizo Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.