Cleared Traditional

K103476 - BRIVOXR285AMX

K103476 is the FDA 510(k) clearance for BRIVOXR285AMX by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K103476 · Ge Medical Systems, LLC · Radiology device
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Jun 2011
Decision
204d
Days
Class 2
Risk

K103476 is an FDA 510(k) clearance for the BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on June 16, 2011 after a review of 204 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Medical Systems, LLC devices

Submission Details

510(k) Number K103476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date June 16, 2011
Days to Decision 204 days
Submission Type Traditional
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
97d slower than avg
Panel avg: 107d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 117
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K103476.
Optima XR200amx, Optima XR220amx
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K080945 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2008