The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Gyrex 2t Prestige Model No. 100-6321-0107 And Gyrex Privilege Model No. 100-6326-0102.
| Device ID | K965044 |
| 510k Number | K965044 |
| Device Name: | GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | Thomas J Spackman |
| Correspondent | Thomas J Spackman 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 | 1996-12-13 |
| Decision Date | 1997-06-16 |
| Summary: | summary |