The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Sceptre-vs.
| Device ID | K021314 |
| 510k Number | K021314 |
| Device Name: | SCEPTRE-VS |
| Classification | System, Image Processing, Radiological |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Robert H Mccarthy |
| Correspondent | Robert H Mccarthy HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-25 |
| Decision Date | 2002-07-02 |
| Summary: | summary |