The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for 3.0.t Signa Vh/i (t/r) Body Imaging Coil.
| Device ID | K003613 |
| 510k Number | K003613 |
| Device Name: | 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| 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 | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-04-03 |