Cleared Traditional

K103330 - BRIVO MR355

K103330 is an FDA 510(k) clearance for BRIVO MR355, manufactured by Ge Hangwei Medical Systems Co., Ltd.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K103330 · Ge Hangwei Medical Systems Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
91d
Days
Class 2
Risk

K103330 is an FDA 510(k) clearance for the BRIVO MR355, OPTIMA MR360. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ge Hangwei Medical Systems Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 11, 2011 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Hangwei Medical Systems Co., Ltd. devices

FDA 510(k) Submission Details - K103330

510(k) Number K103330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2010
Decision Date February 11, 2011
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

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 863
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K103330.
IDEAL IQ SOFTWARE OPTION
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G-SCAN
K110238 · Esaote, S.P.A. · Feb 2011
1.5T OPTIMA MR430S
K103238 · Ge Medical Systems, LLC · Feb 2011
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS
K102344 · Philips Medical Systems Nederland B.V. · Nov 2010
MAGNETOM AERA
K101347 · Siemens Medical Solutions USA, Inc. · Oct 2010
MR RADIATION ONCOLOGY OPTIONS
K102155 · Ge Medical Systems, LLC · Aug 2010