The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for 1w/kg Sar(part Of Version 6-05 Operating System Software).
| Device ID | K962048 |
| 510k Number | K962048 |
| Device Name: | 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Contact | James J Rogers |
| Correspondent | James J Rogers HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-08-14 |
| Summary: | summary |