FDA 510(k) Application Details - K140041

Device Classification Name	More FDA Info for this Device
510(K) Number	K140041
Device Name	ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
Applicant	GENORAY CO., LTD. 3002 DOW AVENUE SUITE 420 TUSTIN, CA 92780 US Other 510(k) Applications for this Company
Contact	KAITLYNN MIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2014
Decision Date	11/28/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review