The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Echelon Oval V 5.1 Mri System.
| Device ID | K153547 |
| 510k Number | K153547 |
| Device Name: | ECHELON Oval V 5.1 MRI System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-11 |
| Decision Date | 2016-03-31 |
| Summary: | summary |