510(k) · Cleared
Recalled · Class III · 2016Ariol Her-2/Neu Ihc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Imaging Corp. · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Jan 8, 2004 after a 220-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 8, 2004
- Review
- 220 days
- Class
- Class II
- Product code
- NOT
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK031715 Ariol Her-2/Neu IhcApplied Imaging Corp. · 2004
- 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 · 3 generations on · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK131140 Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014
Most influential descendants
Showing 4 of 4 · See all- K080564Scanscope XT SystemAperio Technologies · 2009 · cites it directly3descendants
- K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011 · 2 generations on2descendants
- K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015 · 3 generations on0descendants
- K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031715 | Ariol Her-2/Neu Ihc | Applied Imaging Corp. | 2004 | — |
| +1 | K080564 | Scanscope XT System | Aperio Technologies | 2009 | — |
| +2 | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| +3 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +3 | K131140 | Omnyx Idp for HER2 Manual Application | Omnyx, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080564 | Scanscope XT System | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 6, 2016 | Class III | Z-1948-2016 | Nonconforming Material/Component | An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080564 (Aperio Technologies, 2009) has gone furthest, with 3 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 Applied Imaging AriolTM is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative…
Read the full statement (219 words)
The Applied Imaging AriolTM is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.
This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation. When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been established.
The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031715: Ariol Her-2/Neu Ihc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031715
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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