FDA 510(k) Application Details - K140957

Device Classification Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity   More FDA Info for this Device
510(K) Number	K140957
Device Name	Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Applicant	APPLIED SPECTRAL IMAGING LTD. P.O. BOX 4414 (A109) CAESAREA 30889 IL Other 510(k) Applications for this Company
Contact	ILAN SHARON Other 510(k) Applications for this Contact
Regulation Number	864.1860   More FDA Info for this Regulation Number
Classification Product Code	NQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/2014
Decision Date	01/15/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review