510(k) · Cleared
ClearedVirtuoso System for Ihc P53 (DO-7)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Cleared on Apr 19, 2012 as substantially equivalent to K092333 (Bioimagene, Inc., 2010) after a 293-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Apr 19, 2012
- Review
- 293 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053520 (2006). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK053520 Ventana Image Analysis System, Model KI-67Tripath Imaging, Inc. · 2006
- 1 generation backK092333 Pathiam System with Iscan for P53 and KI-67Bioimagene, Inc. · 2010
- This deviceK111872 Virtuoso System for Ihc P53 (DO-7)Ventana Medical Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK121350 Virtuso System for Ihc (DO-7)Ventana Medical Systems, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K121350Virtuso System for Ihc (DO-7)Ventana Medical Systems, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053520 | Ventana Image Analysis System, Model KI-67 | Tripath Imaging, Inc. | 2006 | — |
| −1 | K092333 | Pathiam System with Iscan for P53 and KI-67 | Bioimagene, Inc. | 2010 | — |
| 0 (this device) | K111872 | Virtuoso System for Ihc P53 (DO-7) | Ventana Medical Systems, Inc. | 2012 | — |
| +1 | K121350 | Virtuso System for Ihc (DO-7) | Ventana Medical Systems, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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? (1)
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 |
|---|---|---|---|
| * | K092333 | Pathiam System with Iscan for P53 and KI-67Summary page 1…ystem with iScan for p53 and Ki-67 (Biolmagene, Inc. [now Ventana Digital Pathology], Sunnyvale, CA), cleared under pre-market notification K092333 on October 27, 2010. Both devices are digital pathology and image analysis systems for the consistent assessment o… | 2010 |
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 |
|---|---|---|---|
| K121350 | Virtuso System for Ihc (DO-7) | 2012 | 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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K121350 (Ventana Medical Systems, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K092333.
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. 2012, this device’s year, is highlighted.
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 Virtuoso system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting; review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. The VirtuoSOTM System for p53 (DO-7) is for digital read and image analysis appl ications. This particular…
Read the full statement (310 words)
The Virtuoso system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting; review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape.
The VirtuoSOTM System for p53 (DO-7) is for digital read and image analysis appl ications. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of p53 (DO-7) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRMT M anti-p53 (DO-7) Mouse Monoclonal Primary Antibody assay. The Ventana Medical Systems, Inc. CONFIRMTM anti-p53 assay is indicated for the assessment of p53 protein where mutations have been linked to tumor proliferation. When used with this assay, the VirtuoSOTM System for p53 (DO-7) is indicated for use as an aid in the assessment of p53 status in breast cancer patients (but is not the sole basis for treatment).
Note: The IC p53 (DO-7) Digital Read and Image Analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist -in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of p53 protein. The pathologist should verify agreement with the Image Analysis software application score. The accuracy of the test results depends on the quality of the imrmunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRMTm anti-p53 (DO-7) Mouse Monoclonal Primary Antibody assay used to assure the validity of the. Virtuoso System for IHC p53 Digital Read and Image Analysis scores. The actual correlation of CONFIRMTM anti-p53 (DO-7) Mouse Monoclonal Primary Antibody to clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111872: Virtuoso System for Ihc P53 (DO-7).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111872
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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