The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Modification To: Medrad Spectris Solaris Mr Injector System.
| Device ID | K012950 |
| 510k Number | K012950 |
| Device Name: | MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. ONE MEDRAD DR. Indianola, PA 15051 |
| Contact | Lorraine R Fredes |
| Correspondent | Lorraine R Fredes 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 | 2001-09-04 |
| Decision Date | 2001-10-04 |