Cleared Special

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT (K072439) - FDA 510(k) Clearance

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

K072439 · Ge Medical Systems Ultrasound and Primary Care Dia · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
15d
Days
Class 2
Risk

K072439 is an FDA 510(k) clearance for the GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT. 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 September 14, 2007 after a review of 15 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 K072439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2007
Decision Date September 14, 2007
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 K072439.
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
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APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
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