The following data is part of a premarket notification filed by Hitachi Healthcare Americas Corporation with the FDA for Echelon Oval V6.0a Mri System.
| Device ID | K172110 |
| 510k Number | K172110 |
| Device Name: | ECHELON OVAL V6.0A MRI System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hitachi Healthcare Americas Corporation 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite Hitachi 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 | 2017-07-13 |
| Decision Date | 2018-01-11 |
| Summary: | summary |