Cleared Special

GE SIGNA 3.0T WITH EXCITE MR SYSTEM

K040444 · General Electric Co. · Radiology
Apr 2004
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K040444 is an FDA 510(k) clearance for the GE SIGNA 3.0T WITH EXCITE MR SYSTEM, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on April 14, 2004, 85 days after receiving the submission on January 20, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K040444 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2004
Decision Date April 14, 2004
Days to Decision 85 days
Submission Type Special
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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