FDA 510(k) Applications for Medical Device Product Code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)

FDA 510(k) Applications for Medical Device Product Code "NOT"
(Microscope, Automated, Image Analysis, Operator Intervention)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K080564	APERIO TECHNOLOGIES	SCANSCOPE XT SYSTEM	08/14/2009
K071128	APERIO TECHNOLOGIES	SCANSCOPE XT SYSTEM	10/10/2007
K031715	APPLIED IMAGING CORP.	ARIOL HER-2/NEU IHC	01/08/2004
K062756	BIOIMAGENE, INC.	PATHIAM IMAGING SOFTWARE FOR HER2/NEU	02/20/2007
K080910	BIOIMAGENE, INC.	PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS	02/04/2009
K032113	CHROMA VISION MEDICAL SYSTEMS INC.	ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)	12/23/2003
K141109	LEICA BIOSYSTEMS IMAGING, INC.	APERIO EPATHOLOGY EIHC IVD SYSTEM	07/29/2014
K051282	TRIPATH IMAGING, INC.	VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU	08/16/2005
K111543	VENTANA MEDICAL SYSTEMS, INC.	VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)	10/12/2011
K111755	VENTANA MEDICAL SYSTEMS, INC.	VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)	02/22/2012
K121033	VENTANA MEDICAL SYSTEMS, INC.	VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)	09/06/2013
K121350	VENTANA MEDICAL SYSTEMS, INC.	VIRTUSO SYSTEM FOR IHC (DO-7)	06/01/2012