Product code NOT

Device name: Microscope, Automated, Image Analysis, Operator Intervention
Medical specialty: Hematology
Device class: 2
Regulation number: 864.1860
Review panel: PA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K141109	APERIO EPATHOLOGY EIHC IVD SYSTEM	Leica Biosystems Imaging, Inc.	2014-07-29
K121033	VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)	Ventana Medical Systems, Inc.	2013-09-06
K121350	VIRTUSO SYSTEM FOR IHC (DO-7)	Ventana Medical Systems, Inc.	2012-06-01
K111755	VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)	Ventana Medical Systems, Inc.	2012-02-22
K111543	VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)	Ventana Medical Systems, Inc.	2011-10-12
K080564	SCANSCOPE XT SYSTEM	Aperio Technologies	2009-08-14
K080910	PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS	Bioimagene, Inc.	2009-02-04
K071128	SCANSCOPE XT SYSTEM	Aperio Technologies	2007-10-10
K062756	PATHIAM IMAGING SOFTWARE FOR HER2/NEU	Bioimagene, Inc.	2007-02-20
K051282	VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU	Tripath Imaging, Inc.	2005-08-16
K031715	ARIOL HER-2/NEU IHC	Applied Imaging Corp.	2004-01-08
K032113	ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)	Chroma Vision Medical Systems, Inc.	2003-12-23

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07290016630046	ASI IVD System	APPLIED SPECTRAL IMAGING LTD.	2024-07-02
07290016630039	ASI IVD System	APPLIED SPECTRAL IMAGING LTD.	2022-03-21
07290016630015	GenASIs™ System	APPLIED SPECTRAL IMAGING LTD.	2018-01-25
07290016630008	GenASIs™ System	APPLIED SPECTRAL IMAGING LTD.	2017-01-12

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