Cleared Traditional

K103330 - BRIVO MR355, OPTIMA MR360 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103330 · Ge Hangwei Medical Systems Co., Ltd. · Radiology device
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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

Submission Details

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.

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.

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