Cleared Traditional

IDEAL IQ SOFTWARE OPTION

K103411 · GE Medical Systems · Radiology
Mar 2011
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K103411 is an FDA 510(k) clearance for the IDEAL IQ SOFTWARE OPTION, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on March 22, 2011, 120 days after receiving the submission on November 22, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K103411 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2010
Decision Date March 22, 2011
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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