# K061392: Ikoniscope Fastfish Auto/Amniocyte Test System

- Pathway: 510(k) (Traditional)
- Applicant: Ikonisys, Inc.
- Decided: Aug 1, 2006 after 74 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K925670 (1993). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052577: Ikoniscope Fastfish Amnio Imaging System, Ikonisys, Inc. (2006) Summary page 2.
- K040591: Duet System, Bioview, Ltd. (2004) Summary page 2.

## Most influential descendants
- K062755: Ikoniscope Oncofish Bladder Test System (2007), 0 descendants of its own

## Indications for use
The Ikoniscope fastFISH Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide 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. Following fully automated scanning, the system produces a summary report of the frequency of FISH signals detected from each chromosome of interest as a basis for the diagnostic conclusion. The system also provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion. The Ikoniscope fastFISH Auto/Amniocyte Test System is intended to detect amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X,Y, 13, 18 and 21.

Source page: https://510kreport.com/device/K061392
Methodology: https://510kreport.com/methodology