The following data is part of a premarket notification filed by Emory University with the FDA for Emory Cardiac Toolbox* 2.0 Executing On Nuclear Medicine Computers.
| Device ID | K992450 |
| 510k Number | K992450 |
| Device Name: | EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS |
| Classification | System, Tomography, Computed, Emission |
| Applicant | EMORY UNIVERSITY 1364 CLIFTON RD. N.E. RM. E163 Atlanta, GA 30322 |
| Contact | Ernest V Garcia |
| Correspondent | Ernest V Garcia EMORY UNIVERSITY 1364 CLIFTON RD. N.E. RM. E163 Atlanta, GA 30322 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-22 |
| Decision Date | 1999-10-07 |
| Summary: | summary |