FLAATZ 560


Device Classification Name

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

510(k) Number K111583
Device Name FLAATZ 560
Applicant
DRTECH CORP.
333-1, sangdeawon 1-dong
jungwon-gu
seongnam-shi, gyeonggi-do, 

KR

462-807

Applicant Contact choul-woo shin
Correspondent
DRTECH CORP.
333-1, sangdeawon 1-dong
jungwon-gu
seongnam-shi, gyeonggi-do, 

KR

462-807

Correspodent Contact choul-woo shin
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 06/07/2011
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No