The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge Signa Excite 1.5t Mr System, Ge Signa Excite 3.0t Mr System.
| Device ID | K041476 |
| 510k Number | K041476 |
| Device Name: | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC PO BOX 414 Milwaukee, WI 53188 |
| Contact | Larry A Kroger Ph.d. |
| Correspondent | Larry A Kroger Ph.d. GE MEDICAL SYSTEMS, LLC PO BOX 414 Milwaukee, 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 | 2004-06-03 |
| Decision Date | 2004-06-17 |
| Summary: | summary |