The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad 1.5t Extremity Array.
| Device ID | K973787 |
| 510k Number | K973787 |
| Device Name: | MEDRAD 1.5T EXTREMITY ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Mary A Greenawalt |
| Correspondent | Mary A Greenawalt 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 | 1997-10-06 |
| Decision Date | 1997-12-30 |
| Summary: | summary |