The following data is part of a premarket notification filed by Sony Medical Systems with the FDA for Cinenet Cardiac Image Network.
| Device ID | K924708 |
| 510k Number | K924708 |
| Device Name: | CINENET CARDIAC IMAGE NETWORK |
| Classification | System, X-ray, Angiographic |
| Applicant | SONY MEDICAL SYSTEMS CYNTHIA A. SINCLAIR 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | C/o Mdci |
| Correspondent | C/o Mdci SONY MEDICAL SYSTEMS CYNTHIA A. SINCLAIR 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-18 |
| Decision Date | 1992-12-30 |