The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t Version 2.1u..
| Device ID | K903028 |
| 510k Number | K903028 |
| Device Name: | GYREX 2T VERSION 2.1U. |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ELSCINT, INC. 930 COMMONWEALTH AVE. Boston, MA 02215 |
| Contact | Steve Beer |
| Correspondent | Steve Beer ELSCINT, INC. 930 COMMONWEALTH AVE. Boston, MA 02215 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1990-09-10 |