The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Echelon Oval Mri System.
| Device ID | K113145 |
| 510k Number | K113145 |
| Device Name: | ECHELON OVAL 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 |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-10-25 |
| Decision Date | 2012-05-01 |
| Summary: | summary |