Cleared Traditional

K103730 - GE LUNAR VISCERAL FAT SOFTWARE

K103730 is an FDA 510(k) clearance for GE LUNAR VISCERAL FAT SOFTWARE, manufactured by Ge Medical Systems Ultrasound and Primary Care Dia. The device is a Class 2 Radiology device with product code KGI cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K103730 · Ge Medical Systems Ultrasound and Primary Care Dia · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
136d
Days
Class 2
Risk

K103730 is an FDA 510(k) clearance for the GE LUNAR VISCERAL FAT SOFTWARE. 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 May 6, 2011 after a review of 136 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 Ge Medical Systems Ultrasound and Primary Care Dia devices

FDA 510(k) Submission Details - K103730

510(k) Number K103730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2010
Decision Date May 06, 2011
Days to Decision 136 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 107d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00987298 Completed Observational Industry-sponsored

Technical Validation of Lunar iDXA (GE Healthcare) Visceral Fat Tool

124
Patients (actual)
1
Site
Condition studied Obesity
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Sanjiv Kaul, MD
Sponsor GE Healthcare (industry)
Started 2009-12-01 → Primary completion 2010-06-01
Primary outcome
Agreement between Lunar iDXA and CT measured visceral fat of the abdominal region
Study completed - no results published. This trial concluded in 2010 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - KGI Densitometer, Bone

All 108
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K103730.
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
K113286 · Ge Medical Systems Lunar · Apr 2012
ACCUDXA2
K113616 · Lone Oak Medical Technologies, LLC · Apr 2012
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · Hologic, Inc. · Mar 2012
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265 · Hologic, Inc. · Mar 2011
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
K091325 · Cooper Surgical · Jun 2009
GE LUNAR FEMUR STRENGTH SOFTWARE
K072664 · Ge Medical Systems Ultrasound and Primary Care Dia · Nov 2008