Eizo Nanao Corporation: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Eizo Nanao Corporation” (first 2002, latest 2013), across 1 product code in 1 review panel. Median 510(k) review time under this name: 46 days. 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 |
|---|---|---|
| 2012 | 6 | 120 |
| 2013 | 2 | 36 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 34 | 34 |
Review panels
- Radiology (34)
Most recent Eizo Nanao Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130336 | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 | LLZ | 2013-03-28 | 45 |
| K130070 | 4MP COLOR LCD MONITOR, RADIFORCE RX440 | LLZ | 2013-02-08 | 28 |
| K120451 | 8MP COLOR LCD MONITOR, REDIFORCE RX840 | LLZ | 2012-08-03 | 171 |
| K113562 | 3MP COLOR LCD MONITOR, RADIFORCE RX340 | LLZ | 2012-07-16 | 228 |
| K113240 | 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W | LLZ | 2012-04-20 | 170 |
| K120407 | 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 | LLZ | 2012-04-19 | 70 |
| K113784 | 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 | LLZ | 2012-03-02 | 71 |
| K113844 | RADIFORCE RX240 | LLZ | 2012-02-27 | 61 |
| K113226 | 8MP COLOR LCD MONITOR,RADIFORCE RX840 | LLZ | 2011-12-17 | 46 |
| K112354 | 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 | LLZ | 2011-11-30 | 106 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eizo Nanao Corporation.
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 Corporation (34 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eizo Nanao Corporation?
FDA lists 34 510(k) clearances under the applicant name “Eizo Nanao Corporation” (first 2002, latest 2013), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eizo Nanao Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eizo Nanao Corporation is 46 days.
Which FDA product codes appear under Eizo Nanao Corporation?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 34).
Next steps
- See all 34 Eizo Nanao Corporation clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Eizo Nanao 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.