GE LUNAR VISCERAL FAT SOFTWARE


Device Classification Name

densitometer, bone

510(k) Number K103730
Device Name GE LUNAR VISCERAL FAT SOFTWARE
Applicant
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
3030 ohmeda drive
madison, 
WI 
53718

Applicant Contact chris paulik
Correspondent
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
3030 ohmeda drive
madison, 
WI 
53718

Correspodent Contact chris paulik
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 12/21/2010
Decision Date 05/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Clinical Trials NCT00987298
Reviewed by Third Party No

Combination Product

No