The following data is part of a premarket notification filed by Nuccardiac Software, Inc. with the FDA for Cequal-quantitative Analysis For Cardiolite Executing On The Medasys Digital Systems Computer.
| Device ID | K972509 |
| 510k Number | K972509 |
| Device Name: | CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER |
| Classification | System, Tomography, Computed, Emission |
| Applicant | NUCCARDIAC SOFTWARE, INC. 21520-"G" YORBA LINDA BLVD., Yorba Linda, CA 92887 |
| Contact | Kenneth F Van Train |
| Correspondent | Kenneth F Van Train NUCCARDIAC SOFTWARE, INC. 21520-"G" YORBA LINDA BLVD., Yorba Linda, CA 92887 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-09-08 |
| Summary: | summary |