# K040591: Duet System

- Pathway: 510(k) (Traditional)
- Applicant: Bioview, Ltd.
- Decided: Sep 16, 2004 after 192 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: 3 generations back to K925670 (1993). 7 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030192: Duet System, Bioview, Ltd. (2003) Summary page 2.
- K012103: Bandview System, Applied Spectral Imaging, Ltd. (2001) Summary page 2.
- (no number) Human manual visualization by conventional microscope: named in the summary without a submission number

## Most influential descendants
- K050840: Modification to Duet System (2005), 7 descendants of its own
- K061602: Duet System (2007), 5 descendants of its own
- K050236: Fishview (2005), 4 descendants of its own
- K071398: Scanview, Model SC-300 (2007), 3 descendants of its own
- K101291: Scanview HER2/Neu Fish System (2010), 2 descendants of its own

## Indications for use
The DuetTM System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnosis use as an aiding tool to the pathologist in the detection, classification and counting of cells of interests based on particular color, intensity, size, pattern and shape. The DuetTM System is intended to detect the following cell types: 1. Hematopoietic cells stained by Giemsa stain, lmmunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. 2. Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).

Source page: https://510kreport.com/device/K040591
Methodology: https://510kreport.com/methodology