The following data is part of a premarket notification filed by Hitachi Medical Corp. with the FDA for Oasis Ctl Coil, Od Flexible Body Coil (l And Xl), And Rapid Foot Coil.
| Device ID | K073310 |
| 510k Number | K073310 |
| Device Name: | OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | HITACHI MEDICAL CORP. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Contact | Doug Thistlewaite |
| Correspondent | Doug Thistlewaite HITACHI MEDICAL CORP. 1959 SUMMIT COMMERCE PARK Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-23 |
| Decision Date | 2008-01-18 |
| Summary: | summary |