Barcoview: FDA clearances and approvals
Barcoview has 17 FDA 510(k) clearances (first 2005, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time: 32 days. openFDA lists 1 product recall by a recalling firm named Barcoview.
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 | 17 | 17 |
Review panels
- Radiology (17)
Most recent Barcoview 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062621 | NIO 5MP-21 AND MDNG-5121 CB | LLZ | 2007-03-19 | 195 |
| K062905 | NIO FUSION 4MP; MDNC 4130 | LLZ | 2006-12-29 | 93 |
| K062131 | NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB | LLZ | 2006-11-17 | 114 |
| K061928 | CORONIS COLOR 2MP AND MDCC 2121 | LLZ | 2006-09-05 | 60 |
| K061927 | CORONIS COLOR 3MP AND MDCC 3120-DL | LLZ | 2006-09-05 | 60 |
| K061924 | CORONIS 3MP AND MDCG 3120-CB | LLZ | 2006-09-05 | 60 |
| K061926 | CORONIS 2MP AND MDCG 2121 - CB | LLZ | 2006-08-18 | 42 |
| K052958 | COLOR NIO 2MP, E-2320 C | LLZ | 2005-11-16 | 26 |
| K052529 | E-2320 PA S | LLZ | 2005-09-30 | 16 |
| K052352 | COLOR CORONIS 2MP-21 AND MFCD 2321 | LLZ | 2005-09-30 | 32 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-09-09.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Barcoview have?
Barcoview has 17 FDA 510(k) clearances (first 2005, latest 2007), across 1 product code in 1 review panel.
How long does FDA take to clear Barcoview's 510(k)s?
The median time from FDA receipt to decision across Barcoview's cleared 510(k)s is 32 days.
What devices does Barcoview make?
Its most frequent FDA product codes are LLZ (System, Image Processing, Radiological, 17).
Has Barcoview had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Barcoview; the most recent began 2008-09-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 17 Barcoview clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Barcoview's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.