GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT


Device Classification Name

densitometer, bone

510(k) Number K072439
Device Name GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
Applicant
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
726 heartland trail
madison, 
WI 
53717

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

Correspodent Contact james p raskob
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 08/30/2007
Decision Date 09/14/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No