FDA 510(k) Application Details - K053162

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K053162
Device Name	System, Image Processing, Radiological
Applicant	VOLUME INTERACTIONS PTE LTD 1 KIM SENG PROMENADE #12-01 GREAT WORLD CITY EAST TOWER, SINGAPORE 237994 SG Other 510(k) Applications for this Company
Contact	R. FAREETH 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	11/14/2005
Decision Date	12/09/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review