# K984188: Automated Cellular Imaging System (Acis)

- Pathway: 510(k) (Traditional)
- Applicant: Chroma Vision Medical Systems, Inc.
- Decided: Jul 28, 1999 after 247 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.
14 later devices descend from it; 1 cites it directly.
0 of 16 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 2.
- (no number) Digital analyzer: ChromaVision Medical Systems, Inc.’s Model: named in the summary without a submission number
- (no number) Nikon Biostation: named in the summary without a submission number
- (no number) Human manual visualization by conventional microscopy: named in the summary without a submission number

## Most influential descendants
- K030192: Duet System (2003), 13 descendants of its own
- 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

## Indications for use
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.

Source page: https://510kreport.com/device/K984188
Methodology: https://510kreport.com/methodology