The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t-dlx.
| Device ID | K915601 |
| 510k Number | K915601 |
| Device Name: | GYREX 2T-DLX |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Rochelle Sobel |
| Correspondent | Rochelle Sobel ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1992-02-14 |