The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ge Delta Software Option For Mri.
| Device ID | K031927 |
| 510k Number | K031927 |
| Device Name: | GE DELTA SOFTWARE OPTION FOR MRI |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry Kreger |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2003-07-02 |
| Summary: | summary |