The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t Prestige 100-6321-0107, Gyrex Priviledge 100-6326-0102, Gyrex Prima 1tg 100-6250-0102.
| Device ID | K974614 |
| 510k Number | K974614 |
| Device Name: | GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 |
| 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 | 1997-12-11 |
| Decision Date | 1998-03-04 |
| Summary: | summary |