The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Echelon High Resolution Foot Coil (mr-hrf-150), Echelon Long Bone Coil (mr-lbc-150).
| Device ID | K083086 |
| 510k Number | K083086 |
| Device Name: | ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) |
| Classification | Coil, Magnetic Resonance, Specialty |
| 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 | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-16 |
| Decision Date | 2008-12-05 |
| Summary: | summary |