FDA 510(k) Application Details - K090991

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K090991
Device Name	System, X-Ray, Tomography, Computed
Applicant	E-WOO TECHNOLOGY 256 NORTH SAM HOUSTON PKWY E. SUITE 115 HOUSTON, TX 77060 US Other 510(k) Applications for this Company
Contact	VINCENT LEE Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2009
Decision Date	10/09/2009
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