Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
FDA product code NQN · Class II (moderate risk) · 21 CFR 864.1860 · Hematology
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
15510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140957 | Genasis Hipath Ihc FamilyNQN · Traditional | Applied Spectral Imaging , Ltd. | 01/15/2015SE |
| K140465 | Virtuoso System for Ihc Er (SP1) with Benchmark Ultra StainerNQN · Traditional | Ventana Medical Systems, Inc. | 03/20/2014SE |
| K130515 | Virtuoso System for Ihc Er (Spi)NQN · Traditional | Ventana Medical Systems, Inc. | 11/22/2013SE |
| K121516 | Virtuoso System for Ihc HER2 (4B5)NQN · Traditional | Ventana Medical Systems, Inc. | 09/26/2013SE |
| K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerNQN · Traditional | Ventana Medical Systems, Inc. | 09/19/2013SE |
| K111872 | Virtuoso System for Ihc P53 (DO-7)NQN · Traditional | Ventana Medical Systems, Inc. | 04/19/2012SE |
| K111869 | Virtuoso System for Ihc PR (IE2)NQN · Traditional | Ventana Medical Systems, Inc. | 03/05/2012SE |
| K092333 | Pathiam System with Iscan for P53 and KI-67NQN · Traditional | Bioimagene, Inc. | 10/27/2010SE |
| K073677 | Scanscope XT SystemNQN · Traditional | Aperio Technologies | 08/01/2008SE |
| K061613 | Ventana Image Analysis System - Pathway HER2 (4B5)NQN · Traditional | Tripath Imaging | 01/10/2007SE |
| K062428 | Ventana Image Analysis System, Model ViasNQN · Traditional | Tripath Imaging, Inc. | 09/29/2006SE |
| K053520 | Ventana Image Analysis System, Model KI-67NQN · Traditional | Tripath Imaging, Inc. | 04/11/2006SE |
| K050012 | Ventana Image Analysis SystemNQN · Traditional | Tripath Imaging, Inc. | 05/06/2005SE |
| K033200 | AriolNQN · Traditional | Applied Imaging Corp. | 03/18/2004SE |
| K031363 | Qca (Version 3.1)NQN · Abbreviated | Cell Analysis, Inc. | 02/05/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0877-2021 Class II | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and…When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the… | Roche Molecular Systems, Inc. | 11/23/2020Terminated |
| Z-1948-2016 Class III | Ariol is an automated scanning microscope and image analysis system. It is intended for…An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even… | Leica Biosystems Richmond Inc. | 05/06/2016Terminated |
| Z-1040-2009 | QCA and iQCA software, a video microscopy software system for quantitative estrogen…A change in the software to open up the software architecture to include other analytes other than Estrogen… | Leica Microsystems, Inc. | 11/06/2008Terminated |
| Z-0571-2008 | Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody…Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software… | Ventana Medical Systems Inc | 06/26/2007Terminated |