Cleared Traditional

K103448 - BRIVO XR385

K103448 is the FDA 510(k) clearance for BRIVO XR385 by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K103448 · Ge Medical Systems, LLC · Radiology device
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Aug 2011
Decision
261d
Days
Class 2
Risk

K103448 is an FDA 510(k) clearance for the BRIVO XR385. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 12, 2011 after a review of 261 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 K103448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date August 12, 2011
Days to Decision 261 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
154d slower than avg
Panel avg: 107d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K103448.
XGEO GU60
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K122454 · Fujifilm Medical System U.S.A., Inc. · Nov 2012
FDR IMAGE STITCHING OPTION
K101686 · Fujifilm Medical System U.S.A., Inc. · Oct 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830 · VATECH Co., Ltd. · Jul 2010
DRX-EVOLUTION, MODEL VX3733-SYS
K091889 · Carestream Health, Inc. · Jul 2009