# NTH: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays

- Device class: 2; regulation: 21 CFR 866.4700; FDA's rule: 510(k) required
- FDA decisions: 8
- Recalls: 0 (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: 1
- 2005: 2
- 2008: 1
- 2010: 1
- 2011: 1
- 2013: 1
- 2014: 1

## Most-cited predicates
- DEN040010: Vysis Autovysion System (2004), cited by 3
- K110345: Scanview System (2011), cited by 1
- K043519: Ariol Her-2/Neu Fish (2005), cited by 1
- K101291: Scanview HER2/Neu Fish System (2010), cited by 1
- K042542: Cytovision for Cep XY (2005), cited by 1

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