NQN · Class II · 21 CFR 864.1860

FDA Product Code NQN: Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.

Leading manufacturers include Ventana Medical Systems, Inc., Tripath Imaging, Inc. and Applied Spectral Imaging , Ltd..

15
Total
15
Cleared
242d
Avg days
2004
Since

FDA 510(k) Cleared Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity Devices (Product Code NQN)

15 devices
1–15 of 15
Cleared Jan 15, 2015
GENASIS HIPATH IHC FAMILY
K140957
Applied Spectral Imaging , Ltd.
Pathology · 276d
Cleared Mar 20, 2014
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
K140465
Ventana Medical Systems, Inc.
Pathology · 24d
Cleared Nov 22, 2013
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515
Ventana Medical Systems, Inc.
Pathology · 268d
Cleared Sep 26, 2013
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516
Ventana Medical Systems, Inc.
Pathology · 492d
Cleared Sep 19, 2013
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143
Ventana Medical Systems, Inc.
Pathology · 427d
Cleared Apr 19, 2012
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872
Ventana Medical Systems, Inc.
Pathology · 293d
Cleared Mar 05, 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869
Ventana Medical Systems, Inc.
Pathology · 248d
Cleared Oct 27, 2010
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
K092333
Bioimagene, Inc.
Pathology · 449d
Cleared Aug 01, 2008
SCANSCOPE XT SYSTEM
K073677
Aperio Technologies
Pathology · 217d
Cleared Jan 10, 2007
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
K061613
Tripath Imaging
Pathology · 215d
Cleared Sep 29, 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
K062428
Tripath Imaging, Inc.
Pathology · 42d
Cleared Apr 11, 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
K053520
Tripath Imaging, Inc.
Pathology · 113d
Cleared May 06, 2005
VENTANA IMAGE ANALYSIS SYSTEM
K050012
Tripath Imaging, Inc.
Pathology · 123d
Cleared Mar 18, 2004
ARIOL
K033200
Applied Imaging Corp.
Pathology · 168d
Cleared Feb 05, 2004
QCA (VERSION 3.1)
K031363
Cell Analysis, Inc.
Pathology · 281d

About Product Code NQN - Regulatory Context