GE Healthcare Surgery
Country not established
- Devices
- 1
What GE Healthcare Surgery makes
The company manufactures the OEC 9900 ELITE, a mobile C-arm fluoroscopy system designed for intraoperative imaging in surgical settings. This device provides real-time X-ray imaging to support procedures such as orthopedics, trauma, and vascular interventions, enabling precise visualization of anatomical structures during surgery.
The OEC 9900 ELITE is classified as a Class II medical device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States, where its products are listed for commercial distribution.
Catalogue
Oec 9900 Elite Ref K082781
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ge Healthcare Surgery have in the registry?
The registry currently lists 1 device for Ge Healthcare Surgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ge Healthcare Surgery's devices?
Among its 1 most recently registered device, Ge Healthcare Surgery has devices listed in FDA 510(k) (1 device).
What risk classes do Ge Healthcare Surgery's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ge Healthcare Surgery's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ge Healthcare Surgery in the registry?
The most recently registered devices listed for Ge Healthcare Surgery include OEC 9900 ELITE.