The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Echelon Rapid Pv Coil, Model Mr-pvc-150, Echelon Rapid Foot Coil, Model Mr-rfc-150 And Echelon Rapid Knee Coil.
| Device ID | K081745 |
| 510k Number | K081745 |
| Device Name: | ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Doug Thistlewaite |
| Correspondent | Doug Thistlewaite 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 | 2008-06-19 |
| Decision Date | 2008-08-12 |
| Summary: | summary |