Barcoview
BelgiumFDA 510(k) applicant, unverified
- Devices
- 17
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Barcoview makes
Barcoview manufactures digital mammography systems, including 2MP, 3MP, 4MP, and 5MP models with color and monochrome options, as well as medical flat panel display systems for imaging diagnostics. Their portfolio includes dedicated mammography units (e.g., NIO 5MP MAMMO) and general-purpose digital detectors (e.g., CORONIS and NIO series) for breast and other radiographic imaging applications. Additional products include specialized display systems for medical imaging workflows and digital detectors for plain abdominal (PA) radiography.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. These products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance requirements. Barcoview operates from the United States.
Catalogue
Search and filter all 17 devicesFDA recalls
FDA recall records list 1 recall initiated by Barcoview, initiated on 2008-09-09. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 9 Sep 2008 Z-0276-2009 Unclassified (pre-2012) Terminated The front protective cover may loosen and completely fall off.
Frequently asked questions
How many devices does Barcoview have in the registry?
The registry currently lists 17 devices for Barcoview. Devices recorded under merged duplicate company entries are counted once.
Which registries list Barcoview's devices?
Among its 17 most recently registered devices, Barcoview has devices listed in FDA 510(k) (17 devices).
What risk classes do Barcoview's devices fall under?
Among its 17 most recently registered devices, the classes recorded for Barcoview's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Barcoview?
FDA recall records list 1 recall initiated by Barcoview, the most recent initiated on 2008-09-09. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Barcoview in the registry?
The most recently registered devices listed for Barcoview include CORONIS 2MP AND MDCG 2121 - CB, NIO 2MP-20 AND E-2620 S, MFCD 1219, MFCD 1219 TS and CORONIS 3MP AND MDCG 3120-CB.