The following data is part of a premarket notification filed by Hitachi Medical Systems America, Inc. with the FDA for Mrp-7000/airis Qd C-spine Coil (p/n Mr-qcsc-42,mr-qcsc-52).
| Device ID | K971016 |
| 510k Number | K971016 |
| Device Name: | MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. Twinsburg, OH 44087 |
| Contact | James J Rogers |
| Correspondent | James J Rogers HITACHI MEDICAL SYSTEMS AMERICA, INC. 1963 CASE PKWY. 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 | 1997-03-20 |
| Decision Date | 1997-06-06 |
| Summary: | summary |