# K080909: Iconoscope Oncofish HER2 Test System, Model 2000

- Pathway: 510(k) (Traditional)
- Applicant: Ikonisys, Inc.
- Decided: Oct 17, 2008 after 199 days
- Product code: NTH (System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays)
- Device class: 2
- Regulation: 21 CFR 866.4700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925670 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050840: Modification to Duet System, Bioview, Ltd. (2005) Summary page 1.
- K061602: Duet System, Bioview, Ltd. (2007) Summary page 1.
- DEN040010: Vysis Autovysion System, Vysis (2004). Our reading of the summary gave K041875, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040010, Vysis Autovysion System (Vysis), granted Dec 13, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The Ikoniscope® oncoFISH® her2 Test System is an automated scanning microscope coupled with image analysis, acquisition, and display functions. It is intended for in-vitro diagnosis as an aid to the technologist or pathologist in the detection, classification, and enumeration of cells of interest based on particular characteristics such as intensity, size, shape, or fluorescence. The Ikoniscope® oncoFISH® her2 Test System is intended to detect and quantify chromosome 17 and the HER-2 gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed with the Abbott PathVysion® HER-2 DNA Probe Kit. The Ikoniscope® oncoFISH® her2 Test System is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining Her-2 gene to chromosome 17 signal ratio.

Source page: https://510kreport.com/device/K080909
Methodology: https://510kreport.com/methodology