The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Oasis Rapid Breast Coil, Model Mr-ibc-120 And Oasis Rapid Nv Coil, Model Mr-nvc-120.
| Device ID | K080062 |
| 510k Number | K080062 |
| Device Name: | OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 |
| 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 | 2008-01-09 |
| Decision Date | 2008-02-11 |
| Summary: | summary |