The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Airis Ii.
| Device ID | K994378 |
| 510k Number | K994378 |
| Device Name: | AIRIS II |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Douglas J Thistlethwaite |
| Correspondent | Douglas J Thistlethwaite HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-03-07 |
| Summary: | summary |