FDA 510(k) Application Details - K091918

Device Classification Name	More FDA Info for this Device
510(K) Number	K091918
Device Name	ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
Applicant	GENORAY CO., LTD. 215 S. STATE STREET, STE 100B SALT LAKE CITY, UT 84111 US Other 510(k) Applications for this Company
Contact	SHIN KUK YOO 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	06/30/2009
Decision Date	10/07/2009
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