# Tripath Imaging, Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 5 (2005–2007): 5 510(k) clearances
- Names in FDA's records: Tripath Imaging, Inc. (4); Tripath Imaging (1)
- Product codes: NQN (4), NOT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Bioimagene, Inc.: 2 (https://510kreport.com/company/bioimagene)

## Its most-cited devices
- K062428: Ventana Image Analysis System, Model Vias (2006), cited by 1
- K053520: Ventana Image Analysis System, Model KI-67 (2006), cited by 1

## Recent decisions
- K061613: Ventana Image Analysis System - Pathway HER2 (4B5) (Jan 10, 2007)
- K062428: Ventana Image Analysis System, Model Vias (Sep 29, 2006)
- K053520: Ventana Image Analysis System, Model KI-67 (Apr 11, 2006)
- K051282: Ventana Image Analysis System - HER2/Neu (Aug 16, 2005)
- K050012: Ventana Image Analysis System (May 6, 2005)

Source page: https://510kreport.com/company/tripath-imaging