Atlas FDA

NQN

15 FDA 510(k) clearances · Product code

248 daysmedian time to decision
449 days90th percentile
15clearances measured

FDA profile

Official device name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device class
Class II (moderate risk)
Regulation
21 CFR 864.1860
Medical specialty
Hematology
FDA definition
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
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RecordFirmDate
GENASIS HIPATH IHC FAMILY (K140957)Applied Spectral Imaging , Ltd.2015-01-15
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (K140465)Ventana Medical Systems, Inc.2014-03-20
VIRTUOSO SYSTEM FOR IHC ER (SPI) (K130515)Ventana Medical Systems, Inc.2013-11-22
VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (K121516)Ventana Medical Systems, Inc.2013-09-26
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER (K122143)Ventana Medical Systems, Inc.2013-09-19
VIRTUOSO SYSTEM FOR IHC P53 (DO-7) (K111872)Ventana Medical Systems, Inc.2012-04-19
VIRTUOSO SYSTEM FOR IHC PR (IE2) (K111869)Ventana Medical Systems, Inc.2012-03-05
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 (K092333)Bioimagene, Inc.2010-10-27
SCANSCOPE XT SYSTEM (K073677)Aperio Technologies2008-08-01
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) (K061613)Tripath Imaging2007-01-10
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS (K062428)Tripath Imaging, Inc.2006-09-29
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 (K053520)Tripath Imaging, Inc.2006-04-11
VENTANA IMAGE ANALYSIS SYSTEM (K050012)Tripath Imaging, Inc.2005-05-06
ARIOL (K033200)Applied Imaging Corp.2004-03-18
QCA (VERSION 3.1) (K031363)Cell Analysis, Inc.2004-02-05

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Every clearance here is in the API, with alerts when new ones post.