The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Modification To 3.0t Signa Vh/i Magnetic Resonance System.
| Device ID | K003575 |
| 510k Number | K003575 |
| Device Name: | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Spectroscopic |
| Applicant | GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS P.O. BOX 414 Milwaukee, WI 53188 |
| Product Code | LNI |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-01-17 |