The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Airis Ii Magnetic Resonance Diagnostic Device,interventional Mr Package.
| Device ID | K984280 |
| 510k Number | K984280 |
| Device Name: | AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | James Jochen Rogers |
| Correspondent | James Jochen Rogers HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK 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 | 1998-11-30 |
| Decision Date | 1999-02-08 |
| Summary: | summary |