The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge 0.35t Signa Ovation With Excite Mr System.
| Device ID | K053009 |
| 510k Number | K053009 |
| Device Name: | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-11-17 |
| Summary: | summary |