The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Quad T/l Coil (1.5t, 1.0t & 0.5t) Models M64tlc, M42tlc, M21tlc.
| Device ID | K982919 |
| 510k Number | K982919 |
| Device Name: | MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC |
| Classification | Coil, Magnetic Resonance, Specialty |
| 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 | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-19 |
| Decision Date | 1998-11-02 |
| Summary: | summary |