510(k) · Cleared
ClearedAcis (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. · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Dec 23, 2003 after a 167-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.
- Decided
- Dec 23, 2003
- Review
- 167 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 4 citing it directly.
- This deviceK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK071671 Scanscope XT SystemAperio Technologies · 2007
- Descendant · cites it directly · 3 of its ownK080564 Scanscope XT SystemAperio Technologies · 2009
- Descendant · 2 generations on · 2 of its ownK111543 Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK071128 Scanscope XT SystemAperio Technologies · 2007
- Descendant · 2 generations on · 1 of its ownK141109 Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K071671Scanscope XT SystemAperio Technologies · 2007 · cites it directly4descendants
- K080564Scanscope XT SystemAperio Technologies · 2009 · cites it directly3descendants
- K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011 · 2 generations on2descendants
- K071128Scanscope XT SystemAperio Technologies · 2007 · cites it directly2descendants
- K141109Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032113 | Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2003 | — |
| +1 | K071671 | Scanscope XT System | Aperio Technologies | 2007 | — |
| +1 | K080564 | Scanscope XT System | Aperio Technologies | 2009 | — |
| +2 | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| +1 | K071128 | Scanscope XT System | Aperio Technologies | 2007 | — |
| +2 | K141109 | Aperio Epathology Eihc Ivd System | Leica Biosystems Imaging, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NOT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NOT device
- #1 K260755 OptraSCAN Systemscore 12.2 · 3 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ChromaVision Medical Systems, Inc. ACIS - ER/PR SW Application Named without a submission number | |
| * | — | Human manual visualization by conventional microscopy Named without a submission number |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K071671 (Aperio Technologies, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NOT devicesNOT Microscope, Automated, Image Analysis, Operator Intervention: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NOT
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NOT
Too few NOT 510(k)s in any year since 2007 to give a median.
Recalls per year · NOT
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NOT
1in 2023
MAUDE reports naming product code NOT, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 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 is intended for laboratory use as an accessory to the DakoCytomation HercepTest TM to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin embedded normal and…
Read the full statement (287 words)
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 is intended for laboratory use as an accessory to the DakoCytomation HercepTest TM to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin embedded normal and neoplastic tissue.
The ACIS is capable of detecting and quantifying regions of clinical interest in immunocytochemically stained material that would otherwise be appropriate for manual visualization by conventional microscopy.
When used with the DakoCytomation HercepTestTM, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the ACIS score.
The ACIS system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscopic slides of breast cancer specimens stained for the presence of Her2 receptor protein. The accuracy of the test result depends upon the quality of immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in instructions for DakoCytomation HercepTestTM to assure the validity of the ACIS-assisted Her2 score.
NOTE: All of the patients in the HERCEPTIN® clinical trials were selected using an investigational immunohistochemical clinical trial assay (CTA). None of the patients in those trials were selected using the DakoCytomation HercepTest TM. The DakoCytomation HercepTest TM was compared to the CTA on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the DakoCytomation HercepTest TM to HERCEPTIN® clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032113: 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/K032113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026