The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Mrinnervu(r) Endorectal Prostate Coil Bpx-15.
| Device ID | K926571 |
| 510k Number | K926571 |
| Device Name: | MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. KAPPA MANOR II 271 KAPPA DRIVE Pittsburgh, PA 15238 |
| Contact | John E Stevens |
| Correspondent | John E Stevens MEDRAD, INC. KAPPA MANOR II 271 KAPPA DRIVE Pittsburgh, PA 15238 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-31 |
| Decision Date | 1993-07-20 |