General Electric Medical Systems
Country not established
- Devices
- 6
What General Electric Medical Systems makes
The company produces medical imaging software and digital assistants for diagnostic workflows, including a personal digital assistant for procedural guidance, a CT colonography analysis tool, and cardiac analysis software. It also offers advanced imaging systems like the Definium AMX 700, a cardiac imaging platform, and a volume viewer for post-processing medical scans. Additional products include simulation software for training and a cardiac analysis system for diagnostic reporting.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The portfolio is listed in the FDA’s 510(k) database, reflecting their regulatory authorisation status. The company is based in the United States.
Catalogue
Entegra Pe Personal Digital Assistant Ref K014058
Regimes: 510(k) Registry: 510(k)Ge Definium Amx 700, Model Amx 700 Ref K052897
Regimes: 510(k) Registry: 510(k)Volume Viewer Plus Ref K041521
Regimes: 510(k) Registry: 510(k)Advantage Sim 6.0 Ref K021780
Regimes: 510(k) Registry: 510(k)Cardiq Analysis Iii Ref K041267
Regimes: 510(k) Registry: 510(k)Ct Colonography Ii Ref K041270
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does General Electric Medical Systems have in the registry?
The registry currently lists 6 devices for General Electric Medical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list General Electric Medical Systems's devices?
Among its 6 most recently registered devices, General Electric Medical Systems has devices listed in FDA 510(k) (6 devices).
What risk classes do General Electric Medical Systems's devices fall under?
Among its 6 most recently registered devices, the classes recorded for General Electric Medical Systems's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from General Electric Medical Systems in the registry?
The most recently registered devices listed for General Electric Medical Systems include ENTEGRA PE PERSONAL DIGITAL ASSISTANT, GE DEFINIUM AMX 700, MODEL AMX 700, VOLUME VIEWER PLUS and ADVANTAGE SIM 6.0.