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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2020 | Roche Molecular Systems, Inc. uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 Terminated |
NQN | K140465 |
| May 6, 2016 | Leica Biosystems Richmond Inc. 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, classification, and counting of cells of Terminated |
NQN | K031715 K033200 +1 |
| Mar 24, 2009 | Leica Microsystems, Inc. QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035.
Intended to measu Terminated |
NQN | K031363 |
| Mar 18, 2008 | Ventana Medical Systems Inc 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 Image Analysis System, Ventana Medical Sy Terminated |
NQN | K061613 |
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