Cleared Special

GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM

K043112 · General Electric Co. · Radiology
Nov 2004
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K043112 is an FDA 510(k) clearance for the GE 0.2T SIGNA PROFILE 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 November 24, 2004, 14 days after receiving the submission on November 10, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K043112 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2004
Decision Date November 24, 2004
Days to Decision 14 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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