Cleared Traditional

GE DELTA SOFTWARE OPTION FOR MRI

K031927 · GE Medical Systems · Radiology
Jul 2003
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K031927 is an FDA 510(k) clearance for the GE DELTA SOFTWARE 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 July 2, 2003, 9 days after receiving the submission on June 23, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K031927 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2003
Decision Date July 02, 2003
Days to Decision 9 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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