The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge 0.35t Signa Ovation With Excite Mr System.
| Device ID | K033504 |
| 510k Number | K033504 |
| Device Name: | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger, Ph.d. |
| Correspondent | Larry A Kroger, Ph.d. GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-05 |
| Decision Date | 2003-11-25 |
| Summary: | summary |