Cleared Special

GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (K033504) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033504 · General Electric Co. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2003
Decision
20d
Days
Class 2
Risk

K033504 is an FDA 510(k) clearance for the GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on November 25, 2003 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all General Electric Co. devices

Submission Details

510(k) Number K033504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2003
Decision Date November 25, 2003
Days to Decision 20 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 430
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K033504.
MAGNETOM C! MR SYSTEM
K041111 · Siemens Medical Solutions USA, Inc. · Jul 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444 · General Electric Co. · Apr 2004
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867 · General Electric Co. · Dec 2003
MAGNETOM AVANTO MR SYSTEM
K032428 · Siemens Medical Solutions USA, Inc. · Oct 2003
GE 0.2T SIGNA PROFILE/I MR SYSTEM
K033168 · General Electric Co. · Oct 2003
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
K030874 · General Electric Co. · Mar 2003