Unigon Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Unigon Industries, Inc. makes
Unigon Industries, Inc. manufactures intravascular imaging analyzers, including the AngioScan Spectrum Analyzer, AngioScanE Spectrum Analyzer, and AngioScan Flo MAD Spectrum Analyzer. These devices are designed for spectral analysis of blood flow and vessel characteristics in coronary and peripheral arteries, aiding in diagnostic assessments.
The company’s portfolio is regulated under Class II devices in the US, with products listed via FDA 510(k) clearance. The analyzers are intended for use in clinical settings to support vascular diagnostics. Unigon Industries, Inc. is based in the United States.
Catalogue
Angioscan Spectrum Analyzer Ref K812184
Regimes: 510(k) Registry: 510(k)Angioscane Spectrum Analyzer Ref K834501
Regimes: 510(k) Registry: 510(k)Angioscan Flo Mad Spectrum Analyzer Ref K834525
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Unigon Industries, Inc. have in the registry?
The registry currently lists 3 devices for Unigon Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unigon Industries, Inc.'s devices?
Among its 3 most recently registered devices, Unigon Industries, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Unigon Industries, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Unigon Industries, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Unigon Industries, Inc. in the registry?
The most recently registered devices listed for Unigon Industries, Inc. include ANGIOSCAN SPECTRUM ANALYZER, ANGIOSCANE SPECTRUM ANALYZER and ANGIOSCAN FLO MAD SPECTRUM ANALYZER.