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510(k) K260755

Device
OptraSCAN System
Applicant
Optrascan, Inc.
510(k) number
K260755
Product code
NOT
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-02
Date received
2026-03-09
Regulation
864.1860
Classification name
Microscope, Automated, Image Analysis, Operator Intervention
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Abhi Gholap
Address
2001 Gateway Pl. Suite 150w San Jose CA US 95110 95110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NOT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141109APERIO EPATHOLOGY EIHC IVD SYSTEMLeica Biosystems Imaging, Inc.2014-07-29
K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.2013-09-06
K121350VIRTUSO SYSTEM FOR IHC (DO-7)Ventana Medical Systems, Inc.2012-06-01
K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.2012-02-22
K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.2011-10-12
K080564SCANSCOPE XT SYSTEMAperio Technologies2009-08-14
K080910PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITSBioimagene, Inc.2009-02-04
K071128SCANSCOPE XT SYSTEMAperio Technologies2007-10-10
K062756PATHIAM IMAGING SOFTWARE FOR HER2/NEUBioimagene, Inc.2007-02-20
K051282VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEUTripath Imaging, Inc.2005-08-16
K031715ARIOL HER-2/NEU IHCApplied Imaging Corp.2004-01-08
K032113ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)Chroma Vision Medical Systems, Inc.2003-12-23