The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Hitachi Mrp-7000 Magnetic Rosonance Device.
| Device ID | K911667 |
| 510k Number | K911667 |
| Device Name: | HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Contact | Robert Mccarthy |
| Correspondent | Robert Mccarthy 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 | 1991-04-12 |
| Decision Date | 1991-05-30 |