Brightonix Imaging
South KoreaFDA 510(k) applicant, unverified
- Devices
- 7
What Brightonix Imaging makes
Brightonix Imaging manufactures the PHAROS, a medical imaging device designed for intraoperative imaging, enabling real-time visualization during surgical procedures to enhance precision and guidance.
The PHAROS device is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
Pharos Ref K250170
510(k) 510(k)
Frequently asked questions
How many devices does Brightonix Imaging have in the registry?
The registry currently lists 7 devices for Brightonix Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brightonix Imaging's devices?
Among its 7 most recently registered devices, Brightonix Imaging has devices listed in FDA 510(k) (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Brightonix Imaging's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Brightonix Imaging's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Brightonix Imaging in the registry?
The most recently registered devices listed for Brightonix Imaging include BRIGHTONIX PHAROS and PHAROS.