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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Leica Biosystems Imaging, Inc. Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. Terminated |
NOT | K141109 |
| Mar 7, 2014 | Leica Biosystems Imaging, Inc. HER2 Image Analysis
Manual Read of HER2 Digital Slides
ER/PR Image Analysis
IHC PR Breast Tissue Manual Read of Digital Slides
The ScanScope System is an automated digital slide creation, management, Terminated |
NOT | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.