# K062756: Pathiam Imaging Software for HER2/Neu

- Pathway: 510(k) (Traditional)
- Applicant: Bioimagene, Inc.
- Decided: Feb 20, 2007 after 159 days
- Product code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)
- 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
Longest line of descent: 1 generation back to K032113 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032113: Acis (Automated Cellular Imaging System), Chroma Vision Medical Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K080910: Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits (2009), 0 descendants of its own

## Indications for use
Biolmagene PATHIAM is intended for use as an accessory to the Dako HercepTest® to aid a pathologist in semi-quantitative measurement of HER2/neu (c-erbB-2) in Formalin-fixed, paraffin-embedded breast cancer tissue. When used with the Dako HercepTest it is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. NOTE: The actual correlation of the Dako HercepTest to Herceptin clinical outcome has not been established.

Source page: https://510kreport.com/device/K062756
Methodology: https://510kreport.com/methodology