The following data is part of a premarket notification filed by General Electric Co. with the FDA for Signa Advantage Magnetic Resonance System-hispeed Performance Options.
| Device ID | K941666 |
| 510k Number | K941666 |
| Device Name: | SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroeger |
| Correspondent | Larry A Kroeger GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-05 |
| Decision Date | 1995-06-19 |