The following data is part of a premarket notification filed by Heartware, Inc. with the FDA for Imageview Coronary Angiography Display And Review System.
| Device ID | K972229 |
| 510k Number | K972229 |
| Device Name: | IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | HEARTWARE, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair HEARTWARE, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-13 |
| Decision Date | 1997-10-16 |
| Summary: | summary |