FDA 510(k) Application Details - K102684

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K102684
Device Name	System, Image Processing, Radiological
Applicant	INFINITT CO., LTD. 12F DAERUNG POST TOWER III 182-4 GURO-DONG, GURO-GU SEOUL 152-050 KR Other 510(k) Applications for this Company
Contact	TRISTAN CHOI 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	09/17/2010
Decision Date	10/01/2010
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	Y
Expedited Review