# K980375: Winscan Automated Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Imaging Corp.
- Decided: Jun 9, 1998 after 130 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: 1 generation back to K925670 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925670: IMS-200, Intelligent Medica Imaging, Inc. (1993) Summary page 1.

## Indications for use
WinSCAN is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC).

Source page: https://510kreport.com/device/K980375
Methodology: https://510kreport.com/methodology