The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Ideal Iq Software Option.
| Device ID | K103411 |
| 510k Number | K103411 |
| Device Name: | IDEAL IQ SOFTWARE OPTION |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | GE MEDICAL SYSTEMS 3200 N GRANDVIEW BLVD W-827 Waukesha, WI 53188 |
| Contact | Tracey Fox |
| Correspondent | Tracey Fox GE MEDICAL SYSTEMS 3200 N GRANDVIEW BLVD W-827 Waukesha, WI 53188 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-03-22 |
| Summary: | summary |