The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Ge 0.7t Signa Openspeed With Excite Mr System.
| Device ID | K032795 |
| 510k Number | K032795 |
| Device Name: | GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, LLC 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 | 2003-09-08 |
| Decision Date | 2003-10-08 |
| Summary: | summary |