# Bioimagene, Inc.

- Location (FDA's records): Cupertino, CA
- FDA decisions: 3 (2007–2010): 3 510(k) clearances
- Product codes: NOT (2), NQN (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tripath Imaging, Inc.: 2 (https://510kreport.com/company/tripath-imaging)
- Chroma Vision Medical Systems, Inc.: 1 (https://510kreport.com/company/chroma-vision-medical-systems)

## Firms that cite its devices most
- Ventana Medical Systems, Inc.: 3 (https://510kreport.com/company/ventana-medical-systems)

## Its most-cited devices
- K092333: Pathiam System with Iscan for P53 and KI-67 (2010), cited by 3
- K062756: Pathiam Imaging Software for HER2/Neu (2007), cited by 1

## Recent decisions
- K092333: Pathiam System with Iscan for P53 and KI-67 (Oct 27, 2010)
- K080910: Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits (Feb 4, 2009)
- K062756: Pathiam Imaging Software for HER2/Neu (Feb 20, 2007)

Source page: https://510kreport.com/company/bioimagene