510(k) · Cleared
ClearedVirtuoso (TM) System for Ihc HER2 (4B5)
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 Oct 12, 2011 as substantially equivalent to K080564 (Aperio Technologies, 2009) and 1 other predicate after a 132-day review. Its family tree reaches back 2 generations to 2003. 2 later devices descend from it.
- Decided
- Oct 12, 2011
- Review
- 132 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K032113 (2003). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- 1 generation backK080564 Scanscope XT SystemAperio Technologies · 2009
- This deviceK111543 Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK131140 Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014
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 | K032113 | Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2003 | — |
| −1 | K080564 | Scanscope XT System | Aperio Technologies | 2009 | — |
| 0 (this device) | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| +1 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +1 | K131140 | Omnyx Idp for HER2 Manual Application | Omnyx, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K080564 | Scanscope XT System Our reading of the summary gave K080654, FDA’s number for Pajunk's Kit for Balloon Aided Laparoscopy (PAJUNK GmbH Medizintechnologie). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Aperio ScanScope® XT System”. | 2009 |
| * | K092333 | Pathiam System with Iscan for P53 and KI-67Summary page 1…nt to the Biolmagene PATHIAMTM System with iScan for p53 and Ki-67 (Biolmagene, Inc., Sunnyvale, CA), cleared under pre-market notification K092333 on October 27, 2010. Both of these systems include the same slide scanner (iScan) and other hardware components. T… | 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 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K140957 (Applied Spectral Imaging, Ltd., 2015) has gone furthest, with 0 descendants of its own.
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. 2011, 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 Virtuoso™ System for IHC HER2 (4B35) is for digital read and image analysis applications. This…
Read the full statement (274 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 HER2 (4B35) 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 HER2 protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. PATHWAY® anti-HER2/neu (4B35) Rabbit Monoclonal Primary Antibody. The PATHWAY® anti-HER2/neu (4B35) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.
NOTE: The IHC HER2 4B35 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 HER-2/neu receptor 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 PATHWAY® anti-HER-2/neu (4B35) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the iScan System for IHC HER2 4B35 Digital Read and Image Analysis scores. The actual correlation of PATHWAY® anti-HER-2/neu (4B35) to clinical outcome has not been established.
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/K111543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111543: Virtuoso (TM) System for Ihc HER2 (4B5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111543
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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