The following data is part of a premarket notification filed by Sony Medical Electronics Co. with the FDA for Sony Cine Video System Sme-3500.
| Device ID | K904447 |
| 510k Number | K904447 |
| Device Name: | SONY CINE VIDEO SYSTEM SME-3500 |
| Classification | System, X-ray, Angiographic |
| Applicant | SONY MEDICAL ELECTRONICS CO. SONY DR. Park Ridge, NJ 07656 |
| Contact | Lynne M Bennett |
| Correspondent | Lynne M Bennett SONY MEDICAL ELECTRONICS CO. SONY DR. Park Ridge, NJ 07656 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-28 |
| Decision Date | 1990-10-17 |