The following data is part of a premarket notification filed by Sony Medical Systems with the FDA for Sony Cardiac Analysis And Review Station (cars).
| Device ID | K931170 |
| 510k Number | K931170 |
| Device Name: | SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) |
| Classification | System, X-ray, Angiographic |
| Applicant | SONY MEDICAL SYSTEMS C/O MEDICAL DEVICE CONSULT,INC 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair SONY MEDICAL SYSTEMS C/O MEDICAL DEVICE CONSULT,INC 49 PLAIN STREET 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 | 1993-03-08 |
| Decision Date | 1993-06-14 |