Atlas FDA

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13 FDA 510(k) clearances · Product code

167 daysmedian time to decision
519 days90th percentile
13clearances measured

FDA profile

Official device name
Microscope, Automated, Image Analysis, Operator Intervention
Device class
Class II (moderate risk)
Regulation
21 CFR 864.1860
Medical specialty
Hematology
FDA definition
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
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RecordFirmDate
OptraSCAN System (K260755)Optrascan, Inc.2026-07-02
APERIO EPATHOLOGY EIHC IVD SYSTEM (K141109)Leica Biosystems Imaging, Inc.2014-07-29
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K121033)Ventana Medical Systems, Inc.2013-09-06
VIRTUSO SYSTEM FOR IHC (DO-7) (K121350)Ventana Medical Systems, Inc.2012-06-01
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K111755)Ventana Medical Systems, Inc.2012-02-22
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) (K111543)Ventana Medical Systems, Inc.2011-10-12
SCANSCOPE XT SYSTEM (K080564)Aperio Technologies2009-08-14
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS (K080910)Bioimagene, Inc.2009-02-04
SCANSCOPE XT SYSTEM (K071128)Aperio Technologies2007-10-10
PATHIAM IMAGING SOFTWARE FOR HER2/NEU (K062756)Bioimagene, Inc.2007-02-20
VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU (K051282)Tripath Imaging, Inc.2005-08-16
ARIOL HER-2/NEU IHC (K031715)Applied Imaging Corp.2004-01-08
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K032113)Chroma Vision Medical Systems, Inc.2003-12-23

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