DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE


Device Classification Name

densitometer, bone

510(k) Number K023554
Device Name DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
Original Applicant
GE LUNAR CORP.
726 heartland trail
madison, 
WI 
53717

Original Contact james p raskob
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 10/23/2002
Decision Date 12/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No