Cleared Traditional

GE PROPELLER IMAGING OPTION FOR MRI

K031230 · GE Medical Systems · Radiology
May 2003
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K031230 is an FDA 510(k) clearance for the GE PROPELLER IMAGING OPTION FOR MRI, 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 May 2, 2003, 14 days after receiving the submission on April 18, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K031230 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2003
Decision Date May 02, 2003
Days to Decision 14 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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