DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K073056
Device Name DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
Applicant
VIEWORKS CO., LTD.
307-2, sangdaewon-dong
jungwon-gu, seongnam-city,
gyeonggi-do, 

KR

462-806

Applicant Contact kim raza
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 10/30/2007
Decision Date 11/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No