The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Oasis Mri System.
| Device ID | K211406 |
| 510k Number | K211406 |
| Device Name: | OASIS MRI System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Aaron Pierce |
| Correspondent | Aaron Pierce FUJIFILM Healthcare Americas Corporation 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 | 2021-05-06 |
| Decision Date | 2021-10-07 |