# K062755: Ikoniscope Oncofish Bladder Test System

- Pathway: 510(k) (Traditional)
- Applicant: Ikonisys, Inc.
- Decided: Jan 4, 2007 after 112 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: 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)
- K052577: Ikoniscope Fastfish Amnio Imaging System, Ikonisys, Inc. (2006) Summary page 2.
- K050840: Modification to Duet System, Bioview, Ltd. (2005) Summary page 2.
- K061392: Ikoniscope Fastfish Auto/Amniocyte Test System, Ikonisys, Inc. (2006) Summary page 4.

## Indications for use
The Ikoniscope® oncoFISHTM Bladder 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® oncoFISHTM Bladder Test System is intended to detect cells, derived from urine samples, stained by FISH using commercially available direct labeled DNA probes for chromosomes 3, 7, 17 and loss of 9p21 locus. Following identification, a summary report is generated which may provide the basis for a diagnostic determination by the genetics professional and a gallery of the images scanned is presented for review to permit the professional to confirm or deny the diagnosis.

Source page: https://510kreport.com/device/K062755
Methodology: https://510kreport.com/methodology