NOT — Microscope, Automated, Image Analysis, Operator Intervention Class II
Classification Details
- Product Code
- NOT
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Definition
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K141109 | leica biosystems imaging | APERIO EPATHOLOGY EIHC IVD SYSTEM | July 29, 2014 |
| K121033 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | September 6, 2013 |
| K121350 | ventana medical systems | VIRTUSO SYSTEM FOR IHC (DO-7) | June 1, 2012 |
| K111755 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | February 22, 2012 |
| K111543 | ventana medical systems | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | October 12, 2011 |
| K080564 | aperio technologies | SCANSCOPE XT SYSTEM | August 14, 2009 |
| K080910 | bioimagene | PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS | February 4, 2009 |
| K071128 | aperio technologies | SCANSCOPE XT SYSTEM | October 10, 2007 |
| K062756 | bioimagene | PATHIAM IMAGING SOFTWARE FOR HER2/NEU | February 20, 2007 |
| K051282 | tripath imaging | VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU | August 16, 2005 |
| K031715 | applied imaging | ARIOL HER-2/NEU IHC | January 8, 2004 |
| K032113 | chroma vision medical systems | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) | December 23, 2003 |