Genoray America, Inc.
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- Devices
- 1
What Genoray America, Inc. makes
Genoray America, Inc. manufactures the ZEN-7000, a fluoroscopic X-ray system designed for real-time imaging in medical procedures.
The company’s portfolio is regulated under FDA Class II devices, with the ZEN-7000 authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Zen-7000, Fluoroscopic X-Ray System Ref K103425
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genoray America, Inc. have in the registry?
The registry currently lists 1 device for Genoray America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genoray America, Inc.'s devices?
Among its 1 most recently registered device, Genoray America, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Genoray America, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Genoray America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genoray America, Inc. in the registry?
The most recently registered devices listed for Genoray America, Inc. include ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM.