The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Model: Gyrex Version V.
| Device ID | K896419 |
| 510k Number | K896419 |
| Device Name: | MODEL: GYREX VERSION V |
| 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 | 1989-11-08 |
| Decision Date | 1990-02-02 |