510(k) · Cleared
ClearedVirtuoso System for IHC PR (1E2) using iScan HT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventana Medical Systems, Inc. · OEO Automated Digital Image Manual Interpretation Microscope
Cleared on Jul 16, 2015 as substantially equivalent to K111869 (Ventana Medical Systems, Inc., 2012) and 1 other predicate after a 275-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jul 16, 2015
- Review
- 275 days
- Class
- Class II
- Product code
- OEO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K033200 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK033200 ARIOLApplied Imaging Corp. · 2004 · Recalled
- 3 generations backK073677 Scanscope XT SystemAperio Technologies · 2008
- 2 generations backK111869 Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012
- 1 generation backK122143 Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013
- This deviceK142965 Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033200 | ARIOL | Applied Imaging Corp. | 2004 | 1 |
| −3 | K073677 | Scanscope XT System | Aperio Technologies | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K142965 | Virtuoso System for IHC PR (1E2) using iScan HT | Ventana Medical Systems, Inc. | 2015 | — |
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 OEO? 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? (2)
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)Summary page 5…This VirtuosoTM System for IHC PR (1E2) using the VENTANA iScan HT is substantially equivalent to its immediate predecessors cleared under K111869 on March 5, 2012, and K122143 on September 19, 2013. The only difference between the two is the use… | 2012 |
| * | K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerSummary page 5…C PR (1E2) using the VENTANA iScan HT is substantially equivalent to its immediate predecessors cleared under K111869 on March 5, 2012, and K122143 on September 19, 2013. The only difference between the two is the use of a new scanner. The new iScan HT scanner i… | 2013 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K111869.
How does its category compare?
All OEO devicesOEO Automated Digital Image Manual Interpretation Microscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OEO
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OEO
Too few OEO 510(k)s in any year since 2007 to give a median.
Recalls per year · OEO
No recall names OEO since 2007.
Adverse event reports per year · OEO
1in 2013
MAUDE reports naming product code OEO, 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 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 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) using the VENTANA iScan HT is for the digital read application. This…
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) using the VENTANA iScan HT is for the digital read application. This particular Virtuoso system is intended for use as an aid to the pathologist in the qualitative detection 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 application is an adjunctive computer-assisted methodology for the qualified pathologist in the acquisition and interpretation of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. 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 scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established. This device is intended for IHC slides stained on the BenchMark XT and BenchMark ULTRA stainers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142965: Virtuoso System for IHC PR (1E2) using iScan HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142965
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