The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for 3.0t Prostate Imaging System.
| Device ID | K051349 |
| 510k Number | K051349 |
| Device Name: | 3.0T PROSTATE IMAGING SYSTEM |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Lisa A Ewing |
| Correspondent | Lisa A Ewing MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-24 |
| Decision Date | 2005-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258021072 | K051349 | 000 |
| 10616258009251 | K051349 | 000 |
| 00616258009025 | K051349 | 000 |
| 10850011472177 | K051349 | 000 |