510(k) · Cleared
ClearedVirtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer
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 Sep 19, 2013 as substantially equivalent to K111869 (Ventana Medical Systems, Inc., 2012) after a 427-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Sep 19, 2013
- Review
- 427 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K033200 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK033200 ARIOLApplied Imaging Corp. · 2004 · Recalled
- 2 generations backK073677 Scanscope XT SystemAperio Technologies · 2008
- 1 generation backK111869 Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012
- This deviceK122143 Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK142965 Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142965Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033200 | ARIOL | Applied Imaging Corp. | 2004 | 1 |
| −2 | K073677 | Scanscope XT System | Aperio Technologies | 2008 | — |
| −1 | K111869 | Virtuoso System for Ihc PR (IE2) | Ventana Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer | Ventana Medical Systems, Inc. | 2013 | — |
| +1 | K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Ventana Medical Systems, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K111869 | Virtuoso System for Ihc PR (IE2) | 2012 |
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 |
|---|---|---|---|
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | 2015 | 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 9 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142965 (Ventana Medical Systems, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K111869.
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. 2013, 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 Virtuoso™ System for IHC PR (1E2) is for digital read and image analysis applications. This particular…
Read the full statement (288 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 Virtuoso™ System for IHC PR (1E2) 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 progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment).
Note: The IHC PR (1E2) 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 PR 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 CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122143 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122143: Virtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122143
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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