FDA 510(k) Application Details - K062743

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K062743
Device Name	System, Image Processing, Radiological
Applicant	ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) 1600 KAPIOLANI BLVD. SUITE 1300 HONOLULU, HI 96814 US Other 510(k) Applications for this Company
Contact	JEFFREY CHERN 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	09/14/2006
Decision Date	10/31/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review