# K012138: Modification to Acis (Automated Cellular Imaging System)

- Pathway: 510(k) (Traditional)
- Applicant: Chroma Vision Medical Systems, Inc.
- Decided: Sep 30, 2002 after 447 days
- Product code: MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031363: Qca (Version 3.1) (2004), 0 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. In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (E W R). It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.

Source page: https://510kreport.com/device/K012138
Methodology: https://510kreport.com/methodology