Barco NV Display Systems: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Barco NV Display Systems” (first 1998, latest 2000), across 2 product codes 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 | 0 | — |
| 2013 | 0 | — |
| 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 | 8 | 8 |
| LMD | System, Digital Image Communications, Radiological | 2 | 2 |
Review panels
- Radiology (10)
Most recent Barco NV Display Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001753 | MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-27 | 49 |
| K001748 | MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-27 | 49 |
| K001750 | MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-21 | 43 |
| K001754 | MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-19 | 41 |
| K001752 | MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-19 | 41 |
| K001751 | MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-19 | 41 |
| K001747 | MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 2000-07-13 | 35 |
| K982820 | BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM | LLZ | 1998-10-08 | 58 |
| K980541 | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY | LMD | 1998-04-09 | 57 |
| K972701 | BARCO MWD 321 MEDICAL WORKSTATION DISPLAY | LMD | 1998-01-02 | 168 |
Recalls
openFDA lists no recalls under a recalling firm named Barco NV Display Systems.
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.
- Barco N.V. (60 510(k)s)
- Barco NV Barcoview (14 510(k)s)
- Barco (1 510(k)s)
- Barco Tekstil Sanayi VE Ticaret A.S. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Barco NV Display Systems?
FDA lists 10 510(k) clearances under the applicant name “Barco NV Display Systems” (first 1998, latest 2000), 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 Barco NV Display Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barco NV Display Systems is 46 days.
Which FDA product codes appear under Barco NV Display Systems?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 8); LMD (System, Digital Image Communications, Radiological, 2).
Next steps
- See all 10 Barco NV Display Systems clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Barco NV Display Systems'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.