The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t Prestige, Gyrex Prima Itg, Gyrex Privilege, Gyrex V-ep.
| Device ID | K980306 |
| 510k Number | K980306 |
| Device Name: | GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Steven M Kay |
| Correspondent | Steven M Kay 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 | 1998-01-27 |
| Decision Date | 1998-04-02 |
| Summary: | summary |