ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K103425
Device Name ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
Applicant
GENORAY AMERICA INC.
1073 n. batavia st
orange, 
CA 
92867

Applicant Contact jae kim
Correspondent
GENORAY AMERICA INC.
1073 n. batavia st
orange, 
CA 
92867

Correspodent Contact jae kim
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 11/22/2010
Decision Date 03/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No