Nec Display Solutions , Ltd.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Nec Display Solutions , Ltd.” (first 2006, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 | 0 | — |
| 2013 | 2 | 29 |
| 2014 | 2 | 66 |
| 2015 | 1 | 15 |
| 2016 | 1 | 29 |
| 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 | 12 | 12 |
| PGY | Display, Diagnostic Radiology | 3 | 3 |
Review panels
- Radiology (15)
Most recent Nec Display Solutions , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161057 | Diagnostic Imaging Color LCD Monitor | PGY | 2016-05-13 | 29 |
| K150145 | MD322C8 31.5 Diagnostic Imaging LCD Monitor | PGY | 2015-02-06 | 15 |
| K142951 | MD210C3 21.3 Diagnostic Imaging LCD Monitor | PGY | 2014-12-10 | 61 |
| K133708 | MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR | LLZ | 2014-02-14 | 72 |
| K130772 | MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR | LLZ | 2013-04-18 | 29 |
| K130770 | MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR | LLZ | 2013-04-18 | 29 |
| K111237 | MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY | LLZ | 2011-06-15 | 44 |
| K090218 | MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ | LLZ | 2009-04-15 | 76 |
| K090215 | MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL | LLZ | 2009-04-15 | 76 |
| K083916 | LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD | LLZ | 2009-01-14 | 15 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nec Display Solutions , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nec Display Solutions , Ltd.?
FDA lists 15 510(k) clearances under the applicant name “Nec Display Solutions , Ltd.” (first 2006, latest 2016), across 2 product codes 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 Nec Display Solutions , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nec Display Solutions , Ltd. is 29 days.
Which FDA product codes appear under Nec Display Solutions , Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 12); PGY (Display, Diagnostic Radiology, 3).
Next steps
- See all 15 Nec Display Solutions , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Nec Display Solutions , Ltd.'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.