The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Magnetic Resonance Diagnostic Device.
| Device ID | K953918 |
| 510k Number | K953918 |
| Device Name: | MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
| 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 | 1995-08-18 |
| Decision Date | 1995-09-12 |