# K030192: Duet System

- Pathway: 510(k) (Traditional)
- Applicant: Bioview, Ltd.
- Decided: Aug 20, 2003 after 211 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: 2 generations back to K925670 (1993). 6 ancestors in all.
13 later devices descend from it; 4 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)
- K001420: Slidescan, Applied Imaging Corp. (2000)
- K984188: Automated Cellular Imaging System (Acis), Chroma Vision Medical Systems, Inc. (1999) Summary page 2.
- K012103: Bandview System, Applied Spectral Imaging, Ltd. (2001)
- (no number) Human manual visualization by conventional microscope: named in the summary without a submission number

## Most influential descendants
- K040591: Duet System (2004), 12 descendants of its own
- 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

## Indications for use
The DuetfM 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. This particular application is intended to detect hematopoietic cells positively stained by Giemza stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension. The device can be used without limitation to specific diseases.

Source page: https://510kreport.com/device/K030192
Methodology: https://510kreport.com/methodology