Cleared Traditional

K113616 - ACCUDXA2

K113616 is an FDA 510(k) clearance for ACCUDXA2, manufactured by Lone Oak Medical Technologies, LLC. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K113616 · Lone Oak Medical Technologies, LLC · Radiology device
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Apr 2012
Decision
142d
Days
Class 2
Risk

K113616 is an FDA 510(k) clearance for the ACCUDXA2. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Lone Oak Medical Technologies, LLC (Doylestown, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 142 days - within the typical 510(k) review window.

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 Lone Oak Medical Technologies, LLC devices

FDA 510(k) Submission Details - K113616

510(k) Number K113616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2011
Decision Date April 27, 2012
Days to Decision 142 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
35d slower than avg
Panel avg: 107d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGI Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K113616.
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NHANES WHOLE BODY DXA REFERENCE DATABASE
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