Panels › Hematology › Product code NOT · Class 2
Microscope, Automated, Image Analysis, Operator Intervention
Regulation 864.1860
1510(k)s in 12 months (13 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in NOT
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems, Inc. | 4 | 0 |
| Leica Biosystems Imaging, Inc. | 1 | 2 |
| Aperio Technologies | 2 | 0 |
| Bioimagene, Inc. | 2 | 0 |
| Applied Imaging Corp. | 1 | 0 |
| Chroma Vision Medical Systems, Inc. | 1 | 0 |
| Optrascan, Inc. | 1 | 0 |
| Tripath Imaging, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2026 | K260755 | OptraSCAN System Optrascan, Inc. | NOT |
| Jul 29, 2014 | K141109 | APERIO EPATHOLOGY EIHC IVD SYSTEM Leica Biosystems Imaging, Inc. | NOT |
| Sep 6, 2013 | K121033 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) Ventana Medical Systems, Inc. | NOT |
| Jun 1, 2012 | K121350 | VIRTUSO SYSTEM FOR IHC (DO-7) Ventana Medical Systems, Inc. | NOT |
| Feb 22, 2012 | K111755 | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) Ventana Medical Systems, Inc. | NOT |
| Oct 12, 2011 | K111543 | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) Ventana Medical Systems, Inc. | NOT |
| Aug 14, 2009 | K080564 | SCANSCOPE XT SYSTEM Aperio Technologies | NOT |
| Feb 4, 2009 | K080910 | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS Bioimagene, Inc. | NOT |
| Oct 10, 2007 | K071128 | SCANSCOPE XT SYSTEM Aperio Technologies | NOT |
| Feb 20, 2007 | K062756 | PATHIAM IMAGING SOFTWARE FOR HER2/NEU Bioimagene, Inc. | NOT |
| Aug 16, 2005 | K051282 | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU Tripath Imaging, Inc. | NOT |
| Jan 8, 2004 | K031715 | ARIOL HER-2/NEU IHC Applied Imaging Corp. | NOT |
| Dec 23, 2003 | K032113 | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) Chroma Vision Medical Systems, Inc. | NOT |
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