FDA 510(k) Application Details - K110033

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K110033
Device Name	System, Image Processing, Radiological
Applicant	IMFOU CO., LTD #821 SAMIL PLAZA, 837-26 YEUKSAM-DONG GANGNAM-GU, SEOUL 135-768 KR Other 510(k) Applications for this Company
Contact	Ho Dong Yang Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2011
Decision Date	09/15/2011
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