WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM


Device Classification Name

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

510(k) Number K110801
Device Name WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
Applicant
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC
#33 bldg. yuquan wisdom vale
tsinghua science park
beijing, 

CN

100097

Applicant Contact likun fu
Correspondent
DIRECT DIGITAL IMAGING TECHNOLOGY (BEIJING) INC
#33 bldg. yuquan wisdom vale
tsinghua science park
beijing, 

CN

100097

Correspodent Contact likun fu
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 03/23/2011
Decision Date 08/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No