X-POSURE SYSTEM VERSION 2 RAD


the company

Device Classification Name

densitometer, bone

510(k) Number K002500
Device Name X-POSURE SYSTEM VERSION 2 RAD
Original Applicant
PRONOSCO A/S
555 13th st.
washington, 
DC 
20004

Original Contact jonathan kahan
Regulation Number 892.1170
Classification Product Code
KGI  
Date Received 08/14/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No