Cleared Special

LUNAR IDXA (K052581) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052581 · Ge Medical Systems Ultrasound and Primary Care Dia · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
30d
Days
Class 2
Risk

K052581 is an FDA 510(k) clearance for the LUNAR IDXA. Classified as Densitometer, Bone (product code KGI), Class II - Special Controls.

Submitted by Ge Medical Systems Ultrasound and Primary Care Dia (Madison, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1170 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Medical Systems Ultrasound and Primary Care Dia devices

Submission Details

510(k) Number K052581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2005
Decision Date October 20, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K052581.
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K072847 · Hologic, Inc. · Mar 2008
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
K061561 · Hologic, Inc. · Jul 2006
IVA (MXA II SOFTWARE OPTION)
K060111 · Hologic, Inc. · Apr 2006
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480 · Hologic, Inc. · Oct 2004
PEDIATRIC REFERENCE DATABASE
K041266 · Hologic, Inc. · Aug 2004
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · Hologic, Inc. · Nov 2003