# K052577: Ikoniscope Fastfish Amnio Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ikonisys, Inc.
- Decided: Jan 24, 2006 after 127 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: 4 generations back to K925670 (1993). 8 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K040591: Duet System, Bioview, Ltd. (2004) Summary page 2.

## Most influential descendants
- K061392: Ikoniscope Fastfish Auto/Amniocyte Test System (2006), 1 descendant of its own
- K062755: Ikoniscope Oncofish Bladder Test System (2007), 0 descendants of its own

## Indications for use
The Ikoniscope™fastFISH™ Amnio 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. The Ikoniscope™fastFISH™ Amnio 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/K052577
Methodology: https://510kreport.com/methodology