The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Ecoil Imaging System For Philips.
| Device ID | K063342 |
| 510k Number | K063342 |
| Device Name: | MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS |
| 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 | 2006-11-06 |
| Decision Date | 2006-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10616258009268 | K063342 | 000 |
| 00850011472088 | K063342 | 000 |
| 00850011472095 | K063342 | 000 |
| 00850011472101 | K063342 | 000 |
| 00616258009070 | K063342 | 000 |
| 00616258009087 | K063342 | 000 |
| 00616258009100 | K063342 | 000 |
| 00616258009117 | K063342 | 000 |
| 00616258009131 | K063342 | 000 |
| 00616258009148 | K063342 | 000 |
| 00616258009162 | K063342 | 000 |
| 00616258009179 | K063342 | 000 |
| 00850011472019 | K063342 | 000 |