Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Hematology · 21 CFR 864.1860
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Recent MDR events
5 adverse event reports on file
- UPATH ENTERPRISE SOFTWARE, IVDMar 28, 2023MalfunctionVentana Medical Systems Inc2028492-2023-00024
- UPATH SOFTWARE - SUPPORTAug 7, 2020MalfunctionVentana Medical Systems Inc2028492-2020-00007
- CONFIRM ERMay 25, 2017InjuryVentana Medical Systems Inc2028492-2017-00002
- BENCHMARK XTMay 31, 2016MalfunctionVentana Medical Systems, Inc2028492-2016-00002
- FOCAL POINTFeb 9, 2006OtherTripath Imaging, Inc.1062336-2006-00001
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Leica Microsystems, Inc.TerminatedMar 24, 2009
QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Hig
A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
Z-1040-2009 · View FDA record ↗ - Ventana Medical Systems IncTerminatedMar 18, 2008
Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology I
Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.
Z-0571-2008 · View FDA record ↗ - Roche Molecular Systems, Inc.TerminatedUnknown
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
Z-0877-2021 · View FDA record ↗ - Leica Biosystems Richmond Inc.TerminatedUnknown
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, c
An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.
Z-1948-2016 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
15 clearances for this product code
- Applied Spectral Imaging , Ltd.Jan 15, 2015
K140957 · GENASIS HIPATH IHC FAMILY
- Ventana Medical Systems, Inc.Mar 20, 2014
K140465 · VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
- Ventana Medical Systems, Inc.Nov 22, 2013
K130515 · VIRTUOSO SYSTEM FOR IHC ER (SPI)
- Ventana Medical Systems, Inc.Sep 26, 2013
K121516 · VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
- Ventana Medical Systems, Inc.Sep 19, 2013
K122143 · VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
- Ventana Medical Systems, Inc.Apr 19, 2012
K111872 · VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
- Ventana Medical Systems, Inc.Mar 5, 2012
K111869 · VIRTUOSO SYSTEM FOR IHC PR (IE2)
- Bioimagene, Inc.Oct 27, 2010
K092333 · PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67