SANTEVIEW


Device Classification Name

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

510(k) Number K111312
Device Name SANTEVIEW
Applicant
SEHYUN CO., LTD.
951 starbuck street
unit j
fullerton, 
CA 
92833

Applicant Contact priscilla chung
Correspondent
SEHYUN CO., LTD.
951 starbuck street
unit j
fullerton, 
CA 
92833

Correspodent Contact priscilla chung
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 05/10/2011
Decision Date 07/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No