DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16


Device Classification Name

system, x-ray, stationary

510(k) Number K080553
Device Name DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
Applicant
VIEWORKS CO., LTD.
340 shady grove road
flintville, 
TN 
37335

Applicant Contact charlie mack
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 02/28/2008
Decision Date 04/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No