The following data is part of a premarket notification filed by Cedara Software Corp. with the FDA for Cedara Cardiology Viewer, Cardiology Archive Viewer, Cardiology Cd Viewer.
| Device ID | K002590 |
| 510k Number | K002590 |
| Device Name: | CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER |
| Classification | System, Image Processing, Radiological |
| Applicant | CEDARA SOFTWARE CORP. 6509 AIRPORT RD. Mississauga, Ontario, CA L4v 1s7 |
| Contact | Carol Nakagawa |
| Correspondent | Carol Nakagawa CEDARA SOFTWARE CORP. 6509 AIRPORT RD. Mississauga, Ontario, CA L4v 1s7 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-10-31 |