Panels › Hematology › Product code NQN · Class 2
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Regulation 864.1860
0510(k)s in 12 months (15 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in NQN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems, Inc. | 6 | 1 |
| Tripath Imaging | 4 | 0 |
| Aperio Technologies | 1 | 0 |
| Applied Imaging Corp. | 1 | 0 |
| Applied Spectral Imaging , Ltd. | 1 | 0 |
| Bioimagene, Inc. | 1 | 0 |
| Cell Analysis, Inc. | 1 | 0 |
| Leica Biosystems Richmond Inc. | 0 | 1 |
| Leica Microsystems, Inc. | 0 | 1 |
| Roche Molecular Systems, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2015 | K140957 | GENASIS HIPATH IHC FAMILY Applied Spectral Imaging , Ltd., IL | NQN |
| Mar 20, 2014 | K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc. | NQN |
| Nov 22, 2013 | K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) Ventana Medical Systems, Inc. | NQN |
| Sep 26, 2013 | K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) Ventana Medical Systems, Inc. | NQN |
| Sep 19, 2013 | K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER Ventana Medical Systems, Inc. | NQN |
| Apr 19, 2012 | K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) Ventana Medical Systems, Inc. | NQN |
| Mar 5, 2012 | K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) Ventana Medical Systems, Inc. | NQN |
| Oct 27, 2010 | K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 Bioimagene, Inc. | NQN |
| Aug 1, 2008 | K073677 | SCANSCOPE XT SYSTEM Aperio Technologies | NQN |
| Jan 10, 2007 | K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) Tripath Imaging | NQN |
| Sep 29, 2006 | K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS Tripath Imaging, Inc. | NQN |
| Apr 11, 2006 | K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 Tripath Imaging, Inc. | NQN |
| May 6, 2005 | K050012 | VENTANA IMAGE ANALYSIS SYSTEM Tripath Imaging, Inc. | NQN |
| Mar 18, 2004 | K033200 | ARIOL Applied Imaging Corp. | NQN |
| Feb 5, 2004 | K031363 | QCA (VERSION 3.1) Cell Analysis, Inc. | NQN |
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