The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad/hitachi Breast Imaging Surface Coil.
| Device ID | K955626 |
| 510k Number | K955626 |
| Device Name: | MEDRAD/HITACHI BREAST IMAGING SURFACE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Rodney J Rylands |
| Correspondent | Rodney J Rylands MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-02-27 |