FDA 510(k) Application Details - K090178

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K090178
Device Name	System, Tomography, Computed, Emission
Applicant	NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD NO. 16M SHIJI ROAD HUNNAN NEW DISTRICT SHENYANG, LIAONING 110179 CN Other 510(k) Applications for this Company
Contact	SUN YAN Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2009
Decision Date	04/24/2009
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