510(k) · Cleared
ClearedVirtuoso System for Ihc PR (IE2)
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 Mar 5, 2012 as substantially equivalent to K073677 (Aperio Technologies, 2008) after a 248-day review. Its family tree reaches back 2 generations to 2004. 4 later devices descend from it.
- Decided
- Mar 5, 2012
- Review
- 248 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033200 (2004). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK033200 ARIOLApplied Imaging Corp. · 2004 · Recalled
- 1 generation backK073677 Scanscope XT SystemAperio Technologies · 2008
- This deviceK111869 Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK122143 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
- Descendant · cites it directly · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK121516 Virtuoso System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K122143Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013 · cites it directly1descendant
- K142965Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc. · 2015 · cites it directly0descendants
- K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015 · cites it directly0descendants
- K121516Virtuoso System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033200 | ARIOL | Applied Imaging Corp. | 2004 | 1 |
| −1 | K073677 | Scanscope XT System | Aperio Technologies | 2008 | — |
| 0 (this device) | K111869 | Virtuoso System for Ihc PR (IE2) | Ventana Medical Systems, Inc. | 2012 | — |
| +1 | 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 | — |
| +1 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +1 | K121516 | Virtuoso System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K073677 | Scanscope XT SystemSummary page 1…ubstantially equivalent to the ScanScope(& System for ER and PR (Aperio Technologies, Inc., Vista, CA) cleared under premarket notification K073677 on August 1, 2008. Both devices are digital pathology and image analysis systems for the consistent assessment of… | 2008 |
What descends from it? (4)
4 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 8 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122143 (Ventana Medical Systems, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K073677.
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 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 VirtuosoTM 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/K111869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111869: Virtuoso System for Ihc PR (IE2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111869
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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