510(k) · Cleared
ClearedVirtuoso System for Ihc KI-67 (30-9)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Feb 22, 2012 as substantially equivalent to K092333 (Bioimagene, Inc., 2010) after a 245-day review. Its family tree reaches back 2 generations to 2006. 2 later devices descend from it.
- Decided
- Feb 22, 2012
- Review
- 245 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053520 (2006). 3 ancestors in all. 2 later devices descend from it, 2 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 deviceK111755 Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK121033 Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView 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) | K111755 | Virtuoso System for Ihc KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012 | — |
| +1 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +1 | K121033 | Virtuoso System for Ihc KI-67 (30-9) | Ventana Medical Systems, Inc. | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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? (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? (2)
2 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?
- 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, K140957 (Applied Spectral Imaging, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K092333.
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. 2012, this device’s year, is highlighted.
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 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 Ki67 (30-9) is for digital read and image analysis applications. This particular…
Read the full statement (308 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 Ki67 (30-9) is for digital read and image analysis applications. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of Ki67 (30-9) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary Antibody assay. The Ventana Medical Systems, Inc. CONFIRMTM anti-Ki67 (30-9) assay is indicated for use in assessing the proliferative activity of normal and neoplastic breast tissue. When used with this assay, the VirtuoSOTM System for Ki67 (30-9) is indicated for use as an aid in the assessment of Ki-67 status in breast cancer patients (but is not the sole basis for treatment).
Note: The IHC Ki67 (30-9) 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 Ki67 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 immunohistochemical 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-Ki67 (30-9) Rabbit Monoclonal Primary Antibody assay to assure the validity of the VirtuoSOTM System for Ki67 (30-9) Digital Read and Image Analysis scores. The actual correlation of CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary antibody assay to clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111755: Virtuoso System for Ihc KI-67 (30-9).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111755
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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