Emory University
Country not established
- Devices
- 2
What Emory University makes
Emory University develops software tools for cardiac imaging analysis, including the Emory Cardiac Toolbox and its updated version (2.0), designed to execute on nuclear medicine computers for diagnostic support.
These tools are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The university is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Emory Cardiac Tool Box Ref K980914
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Emory University have in the registry?
The registry currently lists 2 devices for Emory University. Devices recorded under merged duplicate company entries are counted once.
Which registries list Emory University's devices?
Among its 2 most recently registered devices, Emory University has devices listed in FDA 510(k) (2 devices).
What risk classes do Emory University's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Emory University's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Emory University in the registry?
The most recently registered devices listed for Emory University include EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS and EMORY CARDIAC TOOL BOX.