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 Sep 6, 2013 as substantially equivalent to K111755 (Ventana Medical Systems, Inc., 2012) after a 519-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Sep 6, 2013
- Review
- 519 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K053520 (2006). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK053520 Ventana Image Analysis System, Model KI-67Tripath Imaging, Inc. · 2006
- 2 generations backK092333 Pathiam System with Iscan for P53 and KI-67Bioimagene, Inc. · 2010
- 1 generation backK111755 Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2012
- This deviceK121033 Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K053520 | Ventana Image Analysis System, Model KI-67 | Tripath Imaging, Inc. | 2006 | — |
| −2 | K092333 | Pathiam System with Iscan for P53 and KI-67 | Bioimagene, Inc. | 2010 | — |
| −1 | K111755 | Virtuoso System for Ihc KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K111755 | Virtuoso System for Ihc KI-67 (30-9)Summary page 1…es This Virtuoso System for IHIC Ki-67 (30-9) is substantially equivalent to its immediate predecessor with the same name, cleared under KI 111755 on February 22, 2012. The two Virtuoso systems are identical, with the sole difference being the au… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K111755.
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. 2013, 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 IHC Ki-07 (30-9) Digital Read and Image Analysis applications are intended for use as an aid to the…
Read the full statement (281 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 IHC Ki-07 (30-9) Digital Read and Image Analysis applications are intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of KI-67 protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. KiO7 results are indicated for use in assessing the proliferative activity of normal and neoplastic breast tissue. When used with Ventana Medical Systems, Inc. CONFIRM TM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody Assay, it 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 Ki-67 (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 Ki-67 protein. The pathologist should verify agreement with the Image Analysis software application scare. The accuracy of the test results depends on the quality of the immunohlstochemlcal staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRM h anti- Ki-67 (30-9) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the Virtuoso System for 11-4 Ki-67 Digital Read and Image Analysis scores. The actual correlation of CONFIRM" anti-KI-67 (30-9) Rabbit Monoclonal Primary Antibody to clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121033: 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/K121033
Report an extraction error
Are you the manufacturer?
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