Abyzr Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Abyzr Co., Ltd. makes
Abyzr Co., Ltd. manufactures the Aura DR 43C-AG, a flat panel detector designed for digital radiography systems. This device captures X-ray images for diagnostic imaging purposes, enabling high-resolution visualisation of internal body structures.
The Aura DR 43C-AG is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Aura DR 43C-AG flat panel detector Ref K151014
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Abyzr Co., Ltd. have in the registry?
The registry currently lists 1 device for Abyzr Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abyzr Co., Ltd.'s devices?
Among its 1 most recently registered device, Abyzr Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Abyzr Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Abyzr Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abyzr Co., Ltd. in the registry?
The most recently registered devices listed for Abyzr Co., Ltd. include Aura DR 43C-AG flat panel detector.