PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K122155
Device Name PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Applicant
VATECH CO., LTD.
12946 kimberley ln
houston, 
TX 
77079

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

Correspodent Contact dave kim
Regulation Number 872.1800
Classification Product Code
MUH  
Subsequent Product Code
MQB  
Date Received 07/20/2012
Decision Date 09/04/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No