Cleared Special

GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM

K053009 · GE Medical Systems · Radiology
Nov 2005
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K053009 is an FDA 510(k) clearance for the GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM, 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 November 17, 2005, 22 days after receiving the submission on October 26, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K053009 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2005
Decision Date November 17, 2005
Days to Decision 22 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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