The following data is part of a premarket notification filed by Hitachi Medical Corp. Of America with the FDA for Hitachi Dynamic 3d Imaging System,sf-va100.
| Device ID | K945400 |
| 510k Number | K945400 |
| Device Name: | HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 |
| Classification | System, X-ray, Angiographic |
| Applicant | HITACHI MEDICAL CORP. OF AMERICA 660 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Contact | Charles Hottinger |
| Correspondent | Charles Hottinger HITACHI MEDICAL CORP. OF AMERICA 660 WHITE PLAINS RD. Tarrytown, NY 10591 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1995-11-20 |