# K050012: Ventana Image Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Tripath Imaging, Inc.
- Decided: May 6, 2005 after 123 days
- Product code: NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ventana Image Analysis System (VIAS) is an adjanctive computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection, classification and counting of cells of interest based on marker intensity, size and shape using appropriate controls to assure the validity of the VIAS scores. In this application, the VIAS is intended to aid a qualified pathologist in the acquisition and measurement of images to quantify the percentage of positively stained nuclei in for paraffin embedded breast cancer tissue specimens immunohistochemically stained the presence of estrogen receptor (ER) or progesterone receptor (PR) proteins using Ventana's ER and PR reagents as well as Ventana's DAB copper chromogen and nuclear hematoxylin. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer when used with in vitro diagnostic reagents marketed for these indications.

Source page: https://510kreport.com/device/K050012
Methodology: https://510kreport.com/methodology