Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barcoview, Medical Imaging Systems — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
113 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081109 | CORONIS 5MP MAMMO SL, MODEL MDMG 6121 | Barcoview, Medical Imaging Systems | 2008-05-02 | 14 | 0 |
| K073007 | CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL | Barcoview, Medical Imaging Systems | 2008-02-14 | 113 | 0 |
| K072875 | NIO 5MP DISPLAY, MODEL E5620 | Barcoview, Medical Imaging Systems | 2008-01-22 | 105 | 0 |
| K073205 | NIO 5MP, MODEL MDNG-5121 | Barcoview, Medical Imaging Systems | 2007-12-19 | 36 | 0 |
| K070726 | NIO COLOR 3MP AND MDNC 3120 | Barcoview, Medical Imaging Systems | 2007-05-02 | 48 | 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