Cleared Traditional

GE LUNAR VISCERAL FAT SOFTWARE (K103730) - FDA 510(k) Clearance

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

K103730 · Ge Medical Systems Ultrasound and Primary Care Dia · Radiology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 107d · This submission: 136d
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

All 40
Devices cleared under the same product code (KGI) and FDA review panel - the closest regulatory comparables to K103730.
Aria
K180782 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Apr 2018
SINGLE ENERGY (SE) FEMUR EXAMS
K130277 · Hologic, Inc. · May 2013
HOLOGIC VISCERAL FAT SOFTWARE
K113356 · Hologic, Inc. · Mar 2012
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265 · Hologic, Inc. · Mar 2011
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317 · General Electric Co. · Sep 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
K080711 · Hologic, Inc. · Sep 2008