510(k) · Cleared
ClearedVirtuoso System for Ihc ER (Spi)
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 Nov 22, 2013 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Nov 22, 2013
- Review
- 268 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK130515 Virtuoso System for Ihc ER (Spi)Ventana Medical Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK140465 Virtuoso System for Ihc ER (SP1) with Benchmark Ultra StainerVentana Medical Systems, Inc. · 2014 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K130515 | Virtuoso System for Ihc ER (Spi) | Ventana Medical Systems, Inc. | 2013 | — |
| +1 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +1 | K140465 | Virtuoso System for Ihc ER (SP1) with Benchmark Ultra Stainer | Ventana Medical Systems, Inc. | 2014 | 1 |
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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
- Of its descendants, K140957 (Applied Spectral Imaging, Ltd., 2015) has gone furthest, with 0 descendants of its own.
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 systemi provides automated digital slide creation. management; analysis, and viewing. It is inteded for in vitro diagnostic use as an aid to the pathologist in the display, detection, counating, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape. 'Mhe Virtuoso" System for NHC ER (SF 1) is for digital read and image analysis applications. This…
Read the full statement (292 words)
The Virtuoso systemi provides automated digital slide creation. management; analysis, and viewing. It is inteded for in vitro diagnostic use as an aid to the pathologist in the display, detection, counating, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape.
'Mhe Virtuoso" System for NHC ER (SF 1) is for digital read and image analysis applications. This particular Virtuoso systemn is intended for use as an aid to the pathologist in the detection and sani-quantilstive measurement of estrogen receptor (ER) protein i farmalii-fized, paraflln-embcdded neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRM" anti- Estrogen Receptor (ER) (SF1) Rabbit Monoclonal Primary Antibody assay. The CONFIRM" anti- ER (SF1) 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 ERt (SPI) Digital Read and Image Analysis applications are adjunctive computer-asisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cance specimens stained for the presence of ER protein. The pathologist should verfy agreement with the Image Analysis software application sore. Thec accuracy of the test results depends on the quality of the iniuunhistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONPIRM" anti- Estrogen Receptor (ER) (SP3) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoo System for IHC ER Digital Read and Image Analysis scores. The actual correlation of CONFIRM anti-Estrogen Receptor (ER)(SPI) Rabbit Monoclonal Antibody to clinical outcome has not been established.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130515: Virtuoso System for Ihc ER (Spi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130515
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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