The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hitachi Sx-va30 C-arm Fluoroscopic/angiographic System (sx-va30).
| Device ID | K964990 |
| 510k Number | K964990 |
| Device Name: | HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey HITACHI MEDICAL SYSTEMS AMERICA, INC. 12300 TWINBROOK PARKWAY, SUITE 625 Rockville, MD 20852 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-16 |
| Decision Date | 1997-02-26 |
| Summary: | summary |