Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barco NV Barcoview — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
207 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042221 | CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-12-30 | 135 | 0 |
| K042662 | NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-11-22 | 55 | 0 |
| K042942 | MGP 15 DICOM THEATER | Barco NV Barcoview | 2004-11-22 | 28 | 0 |
| K042660 | NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-11-19 | 52 | 0 |
| K042661 | NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-11-19 | 52 | 0 |
| K041508 | BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco NV Barcoview | 2004-08-27 | 81 | 0 |
| K033859 | BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY | Barco NV Barcoview | 2004-06-02 | 174 | 0 |
| K033006 | MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE | Barco NV Barcoview | 2004-04-20 | 270 | 0 |
| K033104 | MGD 2621P MEDICAL GREYSCALE DISPLAY | Barco NV Barcoview | 2004-04-19 | 203 | 0 |
| K033005 | MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY | Barco NV Barcoview | 2004-04-19 | 207 | 0 |
| K033004 | MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY | Barco NV Barcoview | 2004-04-16 | 204 | 0 |
| K033103 | MGD 2621L MEDICAL GREYSCALE DISPLAY | Barco NV Barcoview | 2004-04-16 | 200 | 0 |
| K040040 | NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM | Barco NV Barcoview | 2004-03-29 | 80 | 0 |
| K040041 | NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM | Barco NV Barcoview | 2004-03-29 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda