FDA 510(k) Applications for Medical Device Product Code "NQN"
(Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K073677 | APERIO TECHNOLOGIES | SCANSCOPE XT SYSTEM | 08/01/2008 |
| K033200 | APPLIED IMAGING CORP. | ARIOL | 03/18/2004 |
| K140957 | APPLIED SPECTRAL IMAGING LTD. | GENASIS HIPATH IHC FAMILY | 01/15/2015 |
| K092333 | BIOIMAGENE, INC. | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | 10/27/2010 |
| K031363 | CELL ANALYSIS, INC. | QCA (VERSION 3.1) | 02/05/2004 |
| K061613 | TRIPATH IMAGING | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | 01/10/2007 |
| K050012 | TRIPATH IMAGING, INC. | VENTANA IMAGE ANALYSIS SYSTEM | 05/06/2005 |
| K053520 | TRIPATH IMAGING, INC. | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | 04/11/2006 |
| K062428 | TRIPATH IMAGING, INC. | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | 09/29/2006 |
| K140465 | VENTANA MEDICAL SYSTEMS, INC. | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | 03/20/2014 |
| K130515 | VENTANA MEDICAL SYSTEMS, INC. | VIRTUOSO SYSTEM FOR IHC ER (SPI) | 11/22/2013 |
| K121516 | VENTANA MEDICAL SYSTEMS, INC. | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | 09/26/2013 |
| K111872 | VENTANA MEDICAL SYSTEMS, INC. | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | 04/19/2012 |
| K122143 | VENTANA MEDICAL SYSTEMS, INC. | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | 09/19/2013 |
| K111869 | VENTANA MEDICAL SYSTEMS, INC. | VIRTUOSO SYSTEM FOR IHC PR (IE2) | 03/05/2012 |
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