Barco NV Barcoview: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Barco NV Barcoview” (first 2004, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 108 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 | 14 | 14 |
Review panels
- Radiology (14)
Most recent Barco NV Barcoview 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042221 | CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | LLZ | 2004-12-30 | 135 |
| K042942 | MGP 15 DICOM THEATER | LLZ | 2004-11-22 | 28 |
| K042662 | NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | LLZ | 2004-11-22 | 55 |
| K042661 | NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM | LLZ | 2004-11-19 | 52 |
| K042660 | NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | LLZ | 2004-11-19 | 52 |
| K041508 | BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM | LLZ | 2004-08-27 | 81 |
| K033859 | BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY | LLZ | 2004-06-02 | 174 |
| K033006 | MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE | LLZ | 2004-04-20 | 270 |
| K033104 | MGD 2621P MEDICAL GREYSCALE DISPLAY | LLZ | 2004-04-19 | 203 |
| K033005 | MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY | LLZ | 2004-04-19 | 207 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Barco NV Barcoview.
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 Display Systems (10 510(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 Barcoview?
FDA lists 14 510(k) clearances under the applicant name “Barco NV Barcoview” (first 2004, latest 2004), 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 Barco NV Barcoview?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barco NV Barcoview is 108 days.
Which FDA product codes appear under Barco NV Barcoview?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 14).
Next steps
- See all 14 Barco NV Barcoview clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Barco NV Barcoview'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.