GE LUNAR FEMUR STRENGTH SOFTWARE


Device Classification Name

densitometer, bone

510(k) Number K072664
Device Name GE LUNAR FEMUR STRENGTH SOFTWARE
Applicant
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
726 heartland trail
madison, 
WI 
53717

Applicant Contact james raskob
Correspondent
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
726 heartland trail
madison, 
WI 
53717

Correspodent Contact james raskob
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 09/20/2007
Decision Date 11/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No