The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Spectris Solaris Ep Mr Injector System.
| Device ID | K042784 |
| 510k Number | K042784 |
| Device Name: | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | John M Kiste |
| Correspondent | John M Kiste MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616258022246 | K042784 | 000 |
| 00616258007359 | K042784 | 000 |
| 10616258007141 | K042784 | 000 |
| 00616258005423 | K042784 | 000 |
| 40616258010012 | K042784 | 000 |
| 40616258021872 | K042784 | 000 |
| 40616258021865 | K042784 | 000 |
| 40616258021858 | K042784 | 000 |
| 40616258021612 | K042784 | 000 |
| 00616258007786 | K042784 | 000 |
| 00616258008745 | K042784 | 000 |
| 00616258008790 | K042784 | 000 |
| 00616258021256 | K042784 | 000 |
| 00616258020280 | K042784 | 000 |
| 00616258010267 | K042784 | 000 |
| 40616258010029 | K042784 | 000 |
| 40616258009993 | K042784 | 000 |
| 00616258008844 | K042784 | 000 |
| 00616258008837 | K042784 | 000 |
| 00616258008806 | K042784 | 000 |
| 40616258021605 | K042784 | 000 |