DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC


Device Classification Name

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

510(k) Number K122182
Device Name DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
Applicant
RAYENCE CO., LTD
12946 kimberley ln
houston, 
TX 
77079

Applicant Contact dave kim
Correspondent
RAYENCE CO., LTD
12946 kimberley ln
houston, 
TX 
77079

Correspodent Contact dave kim
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 07/23/2012
Decision Date 08/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No