510(k) · Cleared
ClearedModification to Acis (Automated Cellular Imaging System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chroma Vision Medical Systems, Inc. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on Sep 30, 2002 after a 447-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Sep 30, 2002
- Review
- 447 days
- Class
- Class II
- Product code
- MYA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012138 Modification to Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK031363 Qca (Version 3.1)Cell Analysis, Inc. · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K031363Qca (Version 3.1)Cell Analysis, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012138 | Modification to Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2002 | — |
| +1 | K031363 | Qca (Version 3.1) | Cell Analysis, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031363 | Qca (Version 3.1) | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031363 (Cell Analysis, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MYA devicesMYA Immunohistochemistry Antibody Assay, Estrogen Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MYA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MYA
Too few MYA 510(k)s in any year since 2007 to give a median.
Recalls per year · MYA
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MYA
2in 2025
MAUDE reports naming product code MYA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K012138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012138: Modification to Acis (Automated Cellular Imaging System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012138
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026