510(k) · Cleared
ClearedVentana Image Analysis System, Model Vias
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tripath Imaging, Inc. · NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Cleared on Sep 29, 2006 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Sep 29, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK062428 Ventana Image Analysis System, Model ViasTripath Imaging, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK092333 Pathiam System with Iscan for P53 and KI-67Bioimagene, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK111755 Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK111543 Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK111872 Virtuoso System for Ihc P53 (DO-7)Ventana Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K092333Pathiam System with Iscan for P53 and KI-67Bioimagene, Inc. · 2010 · cites it directly7descendants
- K111755Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2012 · 2 generations on2descendants
- K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011 · 2 generations on2descendants
- K111872Virtuoso System for Ihc P53 (DO-7)Ventana Medical Systems, Inc. · 2012 · 2 generations on1descendant
- K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062428 | Ventana Image Analysis System, Model Vias | Tripath Imaging, Inc. | 2006 | — |
| +1 | K092333 | Pathiam System with Iscan for P53 and KI-67 | Bioimagene, Inc. | 2010 | — |
| +2 | K111755 | Virtuoso System for Ihc KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012 | — |
| +2 | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| +2 | K111872 | Virtuoso System for Ihc P53 (DO-7) | Ventana Medical Systems, Inc. | 2012 | — |
| +3 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 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 NQN? 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092333 | Pathiam System with Iscan for P53 and KI-67 | 2010 | 7 |
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, K092333 (Bioimagene, Inc., 2010) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NQN devicesNQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NQN
427in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQN
1in 2023
MAUDE reports naming product code NQN, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 427 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ventana Image Analysis System (VIASTM) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection, classification and counting of cells of interest based on marker intensity, size and shape using appropriate controls to assure the validity of the VIAS scores. In this application, the VIAS is intended to aid a qualified pathologist…
Read the full statement (220 words)
The Ventana Image Analysis System (VIASTM) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection, classification and counting of cells of interest based on marker intensity, size and shape using appropriate controls to assure the validity of the VIAS scores.
In this application, the VIAS is intended to aid a qualified pathologist in the acquisition and measurement of images to quantify the percentage of positively stained nuclei in formalin-fixed, paraffin-embedded breast cancer tissue specimens immunohistochemically stained for the presence of p53 proteins using Ventana's reagents and nuclear hematoxylin. p53 over-expression is indicated for use as a marker of alterations of the p53 gene in breast tissue when used with in vitro diagnostic reagents marketed for these indications.
The VIAS 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 p53 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 Ventana p53 assay to assure the validity of the vIAs-assisted p53 assessment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062428: Ventana Image Analysis System, Model Vias.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062428
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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