# NOT: Microscope, Automated, Image Analysis, Operator Intervention

- Device class: 2; regulation: 21 CFR 864.1860; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 1 (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)
- 2003: 1
- 2004: 1
- 2005: 1
- 2007: 2
- 2009: 2
- 2011: 1
- 2012: 2
- 2013: 1
- 2014: 1
- 2026: 1

## Most-cited predicates
- K032113: Acis (Automated Cellular Imaging System) (2003), cited by 4
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), cited by 2
- K111755: Virtuoso System for Ihc KI-67 (30-9) (2012), cited by 2
- K031715: Ariol Her-2/Neu Ihc (2004), cited by 1
- K141109: Aperio Epathology Eihc Ivd System (2014), cited by 1
- K080564: Scanscope XT System (2009), cited by 1
- K071128: Scanscope XT System (2007), cited by 1
- K062756: Pathiam Imaging Software for HER2/Neu (2007), cited by 1

Source page: https://510kreport.com/product-code/NOT
Data by year (CSV): https://510kreport.com/product-code/NOT.csv