The following data is part of a premarket notification filed by Cardiac Mariners, Inc. with the FDA for Vasco Scanning Beam Digital X-ray System.
| Device ID | K982345 |
| 510k Number | K982345 |
| Device Name: | VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CARDIAC MARINERS, INC. 120-B ALBRIGHT WAY Los Gatos, CA 95030 |
| Contact | E. Bruce Floyd |
| Correspondent | E. Bruce Floyd CARDIAC MARINERS, INC. 120-B ALBRIGHT WAY Los Gatos, CA 95030 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-06 |
| Decision Date | 1998-09-01 |