Barcoview, Medical Imaging Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Barcoview, Medical Imaging Systems” (first 2007, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 48 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 | 5 | 5 |
Review panels
- Radiology (5)
Most recent Barcoview, Medical Imaging Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081109 | CORONIS 5MP MAMMO SL, MODEL MDMG 6121 | LLZ | 2008-05-02 | 14 |
| K073007 | CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL | LLZ | 2008-02-14 | 113 |
| K072875 | NIO 5MP DISPLAY, MODEL E5620 | LLZ | 2008-01-22 | 105 |
| K073205 | NIO 5MP, MODEL MDNG-5121 | LLZ | 2007-12-19 | 36 |
| K070726 | NIO COLOR 3MP AND MDNC 3120 | LLZ | 2007-05-02 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Barcoview, Medical Imaging 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.
- Barcoview (17 510(k)s)
- Barcoview Mis Edinburgh (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Barcoview, Medical Imaging Systems?
FDA lists 5 510(k) clearances under the applicant name “Barcoview, Medical Imaging Systems” (first 2007, latest 2008), 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 Barcoview, Medical Imaging Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barcoview, Medical Imaging Systems is 48 days.
Which FDA product codes appear under Barcoview, Medical Imaging Systems?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5).
Next steps
- See all 5 Barcoview, Medical Imaging Systems clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Barcoview, Medical Imaging 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.