Cleared Traditional

K103476 - BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX

K103476 is an FDA 510(k) clearance for BRIVOXR285AMX, manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K103476

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.

IZL Device Classification - Class 2, Special Controls

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 176
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K103476.
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K100449 · Minxray, Inc. · Apr 2010