Cleared Traditional

ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS (K113286) - FDA 510(k) Clearance

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

K113286 · Ge Medical Systems Lunar · Radiology device
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Apr 2012
Decision
172d
Days
Class 2
Risk

K113286 is an FDA 510(k) clearance for the ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Ge Medical Systems Lunar (Madison, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 172 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - 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 Lunar devices

Submission Details

510(k) Number K113286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date April 27, 2012
Days to Decision 172 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
65d slower than avg
Panel avg: 107d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGI Densitometer, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1170
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 - KGI Densitometer, Bone

All 40
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K113286.
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NHANES WHOLE BODY DXA REFERENCE DATABASE
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GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · General Electric Co. · Sep 2008