The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Iris Bilateral Tmj.
| Device ID | K953248 |
| 510k Number | K953248 |
| Device Name: | IRIS BILATERAL TMJ |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Contact | James Jochen Rogers |
| Correspondent | James Jochen 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 | 1995-07-11 |
| Decision Date | 1995-10-23 |