Emory University is one of 13055 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Emory University - FDA 510(k) Cleared Devices
Recent clearances: EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS, EMORY CARDIAC TOOL BOX
2
Total
2
Cleared
0
Denied
Emory University, is a leading research institution based in Atlanta, Georgia. The university conducts groundbreaking research across nine colleges and schools, with a focus on advancing knowledge in service to humanity.
Emory received 2 FDA 510(k) clearances from 2 total submissions in the Radiology device category. The company's cleared devices include the Emory Cardiac Toolbox and related cardiac imaging software. Clearances were granted between 1998 and 1999. Emory's regulatory activity in medical device development is now historical, with no submissions recorded in recent years.
The cleared devices focused on cardiac imaging and nuclear medicine applications, reflecting the university's strength in diagnostic imaging research and clinical innovation.
For detailed information on device names, product codes, and specific clearance dates, consult the FDA's 510(k) database.
FDA 510(k) Regulatory Record - Emory University
2 devices