NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity Class II
Classification Details
- Product Code
- NQN
- 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 nuclear intensity and percent positivity with operator intervention.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K140957 | applied spectral imaging | GENASIS HIPATH IHC FAMILY | January 15, 2015 |
| K140465 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | March 20, 2014 |
| K130515 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC ER (SPI) | November 22, 2013 |
| K121516 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | September 26, 2013 |
| K122143 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | September 19, 2013 |
| K111872 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | April 19, 2012 |
| K111869 | ventana medical systems | VIRTUOSO SYSTEM FOR IHC PR (IE2) | March 5, 2012 |
| K092333 | bioimagene | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | October 27, 2010 |
| K073677 | aperio technologies | SCANSCOPE XT SYSTEM | August 1, 2008 |
| K061613 | tripath imaging | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | January 10, 2007 |
| K062428 | tripath imaging | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | September 29, 2006 |
| K053520 | tripath imaging | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | April 11, 2006 |
| K050012 | tripath imaging | VENTANA IMAGE ANALYSIS SYSTEM | May 6, 2005 |
| K033200 | applied imaging | ARIOL | March 18, 2004 |
| K031363 | cell analysis | QCA (VERSION 3.1) | February 5, 2004 |