Cleared Traditional

K161682 - GE Lunar DXA Bone Densitometers with enCORE version 17 (FDA 510(k) Clearance)

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

K161682 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology device
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Dec 2016
Decision
168d
Days
Class 2
Risk

K161682 is an FDA 510(k) clearance for the GE Lunar DXA Bone Densitometers with enCORE version 17. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Madison, US). The FDA issued a Cleared decision on December 2, 2016 after a review of 168 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 Ultrasound & Primary Care Diagnostics, LLC devices

Submission Details

510(k) Number K161682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2016
Decision Date December 02, 2016
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
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

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