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 |