The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Signa Excite Mr Surgical Option.
| Device ID | K043262 |
| 510k Number | K043262 |
| Device Name: | GE SIGNA EXCITE MR SURGICAL OPTION |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE HEALTHCARE P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE HEALTHCARE 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 | 2004-11-24 |
| Decision Date | 2005-01-12 |
| Summary: | summary |