NQN — Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity Class II
FDA product code NQN covers "Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity", a Class II medical device regulated under 21 CFR 864.1860. Submissions are reviewed by the Hematology panel. At least 15 recent 510(k) clearances have been granted under this product code.
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 |