510(k) · Cleared
Recalled · Class III · 2016Ariol Her-2/Neu Fish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Imaging Corp. · NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Cleared on Apr 25, 2005 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled once.
- Decided
- Apr 25, 2005
- Review
- 126 days
- Class
- Class II
- Product code
- NTH
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK043519 Ariol Her-2/Neu FishApplied Imaging Corp. · 2005
- Descendant · cites it directly · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · 2 generations on · 0 of its ownK130775 Duet SystemBioview, Ltd. · 2014
- Descendant · 4 generations on · 0 of its ownK122554 Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061602Duet SystemBioview, Ltd. · 2007 · cites it directly5descendants
- K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010 · 2 generations on2descendants
- K110345Scanview SystemApplied Spectral Imaging · 2011 · 3 generations on1descendant
- K130775Duet SystemBioview, Ltd. · 2014 · 2 generations on0descendants
- K122554Genasis Scanview SystemApplied Spectral Imaging, Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043519 | Ariol Her-2/Neu Fish | Applied Imaging Corp. | 2005 | — |
| +1 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +2 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +3 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +2 | K130775 | Duet System | Bioview, Ltd. | 2014 | — |
| +4 | K122554 | Genasis Scanview System | Applied Spectral Imaging, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 NTH? 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061602 | Duet System | 2007 | 5 |
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, K061602 (Bioview, Ltd., 2007) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NTH devicesNTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTH
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NTH
Too few NTH 510(k)s in any year since 2007 to give a median.
Recalls per year · NTH
No recall names NTH since 2007.
Adverse event reports per year · NTH
1in 2024
MAUDE reports naming product code NTH, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect…
Read the full statement (208 words)
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 particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The PathVysion kit is also indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the PathVysion kit provides the probes that offer direct visualization and manual enumeration of the HER2 and Chromosome 17 genes with a fluorescent microscope, the Ariol may be used as an accessory that provides automated enumeration.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043519: Ariol Her-2/Neu Fish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043519
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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