Product code NQN

Device name: Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
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 nuclear intensity and percent positivity with operator intervention.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140957	GENASIS HIPATH IHC FAMILY	Applied Spectral Imaging , Ltd.	2015-01-15
K140465	VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER	Ventana Medical Systems, Inc.	2014-03-20
K130515	VIRTUOSO SYSTEM FOR IHC ER (SPI)	Ventana Medical Systems, Inc.	2013-11-22
K121516	VIRTUOSO SYSTEM FOR IHC HER2 (4B5)	Ventana Medical Systems, Inc.	2013-09-26
K122143	VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER	Ventana Medical Systems, Inc.	2013-09-19
K111872	VIRTUOSO SYSTEM FOR IHC P53 (DO-7)	Ventana Medical Systems, Inc.	2012-04-19
K111869	VIRTUOSO SYSTEM FOR IHC PR (IE2)	Ventana Medical Systems, Inc.	2012-03-05
K092333	PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67	Bioimagene, Inc.	2010-10-27
K073677	SCANSCOPE XT SYSTEM	Aperio Technologies	2008-08-01
K061613	VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)	Tripath Imaging	2007-01-10
K062428	VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS	Tripath Imaging, Inc.	2006-09-29
K053520	VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67	Tripath Imaging, Inc.	2006-04-11
K050012	VENTANA IMAGE ANALYSIS SYSTEM	Tripath Imaging, Inc.	2005-05-06
K033200	ARIOL	Applied Imaging Corp.	2004-03-18
K031363	QCA (VERSION 3.1)	Cell Analysis, Inc.	2004-02-05

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
00849832011576	Leica Biosystems Ariol Cable, stage sensor	Leica Biosystems Richmond, Inc.	2017-03-29
07290016630008	GenASIs™ System	APPLIED SPECTRAL IMAGING LTD.	2017-01-12
00849832011361	Leica Biosystems Ariol Beveled Edge Slide Holder	Leica Biosystems Richmond, Inc.	2016-12-02
04015630985043	VIRTUOSO System for IHC	VENTANA MEDICAL SYSTEMS, INC.	2016-09-24
00849832007845	Leica Biosystems Ariol TMA Module	Leica Biosystems Richmond, Inc.	2016-09-19
00815477020051	eIHC IVD bundle CS2- 2500	LEICA BIOSYSTEMS IMAGING, INC	2016-09-19
00815477020068	eIHC IVD bundle AT Turbo-2500	LEICA BIOSYSTEMS IMAGING, INC	2016-09-19
00849832003823	Leica Biosystems Ariol Review Station	Leica Biosystems Richmond, Inc.	2016-09-17
00849832007852	Leica Biosystems Ariol Barcode Roll	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003830	Leica Biosystems Ariol Review Software	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003847	Leica Biosystems Ariol Fluorescent Module	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003854	Leica Biosystems Ariol IHC Module	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003861	Leica Biosystems Ariol Rare Event Module	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003878	Leica Biosystems Ariol Workstation PC for Legacy Harware	Leica Biosystems Richmond, Inc.	2016-09-17
00849832007814	Leica Biosystems Ariol Slide Exporter (SCN for DIH)	Leica Biosystems Richmond, Inc.	2016-09-17
00849832007821	Leica Biosystems Ariol Batch Processing Module	Leica Biosystems Richmond, Inc.	2016-09-17
00849832007920	Leica Biosystems Ariol Fluorescent Unit	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003816	Leica Ariol SL200 Basw Workstation	Leica Biosystems Richmond, Inc.	2016-09-17
00849832003809	Leica Biosystems Ariol DM6000B Workstation	Leica Biosystems Richmond, Inc.	2016-09-17
00849832010425	Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished	Leica Biosystems Richmond, Inc.	2016-09-17
00849832010418	Leica Biosystems Ariol DM6000 B Ariol PL200	Leica Biosystems Richmond, Inc.	2016-09-17
00849832010340	Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished	Leica Biosystems Richmond, Inc.	2016-09-17
00849832010333	Leica Biosystems Ariol DM6000 B Basic Configuration Ariol	Leica Biosystems Richmond, Inc.	2016-09-17
00849832009511	Leica Biosystems Ariol Leica DM6000B Ariol	Leica Biosystems Richmond, Inc.	2016-09-17
00849832009504	Leica Biosystems Ariol MSCOPE Leica DM6000B BZ03 Ariol Multibay	Leica Biosystems Richmond, Inc.	2016-09-17
00849832007944	Leica Biosystems Ariol UPS 220V	Leica Biosystems Richmond, Inc.	2016-09-17
00849832007937	Leica Biosystems Ariol UPS 110V	Leica Biosystems Richmond, Inc.	2016-09-17

Product code NQN

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