Dexin Medical Imaging Technology Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 1
What Dexin Medical Imaging Technology Co., Ltd. makes
Dexin Medical Imaging Technology Co., Ltd. manufactures the FACT Medical Imaging System, a device designed for diagnostic imaging applications. This system is intended for use in medical environments to capture detailed internal images of the body, aiding in the assessment of anatomical structures and potential pathologies.
The FACT Medical Imaging System is classified as a Class II medical device under regulatory frameworks and is listed in the FDA’s 510(k) registry. The company is based in the United States, adhering to applicable domestic regulatory standards for imaging equipment.
Catalogue
FACT Medical Imaging Sysytem Ref K143586
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dexin Medical Imaging Technology Co., Ltd. have in the registry?
The registry currently lists 1 device for Dexin Medical Imaging Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dexin Medical Imaging Technology Co., Ltd.'s devices?
Among its 1 most recently registered device, Dexin Medical Imaging Technology Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Dexin Medical Imaging Technology Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dexin Medical Imaging Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dexin Medical Imaging Technology Co., Ltd. in the registry?
The most recently registered devices listed for Dexin Medical Imaging Technology Co., Ltd. include FACT Medical Imaging Sysytem.