# NQN: Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

- Device class: 2; regulation: 21 CFR 864.1860; FDA's rule: 510(k) required
- FDA decisions: 15
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 2
- 2005: 1
- 2006: 2
- 2007: 1
- 2008: 1
- 2010: 1
- 2012: 2
- 2013: 3
- 2014: 1
- 2015: 1

## Most-cited predicates
- K111869: Virtuoso System for Ihc PR (IE2) (2012), cited by 4
- K092333: Pathiam System with Iscan for P53 and KI-67 (2010), cited by 3
- K073677: Scanscope XT System (2008), cited by 2
- K130515: Virtuoso System for Ihc ER (Spi) (2013), cited by 2
- K062428: Ventana Image Analysis System, Model Vias (2006), cited by 1
- K053520: Ventana Image Analysis System, Model KI-67 (2006), cited by 1
- K111872: Virtuoso System for Ihc P53 (DO-7) (2012), cited by 1
- K122143: Virtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer (2013), cited by 1
- K033200: ARIOL (2004), cited by 1

Source page: https://510kreport.com/product-code/NQN
Data by year (CSV): https://510kreport.com/product-code/NQN.csv