The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Quad C-spine Coil, 1.5t Model, M64csc, 1.0t Model M42csc.
| Device ID | K982959 |
| 510k Number | K982959 |
| Device Name: | MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Jim Ferguson Jr |
| Correspondent | Jim Ferguson Jr MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-24 |
| Decision Date | 1998-11-03 |
| Summary: | summary |