510(k) · Cleared
ClearedScanscope XT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aperio Technologies · NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Cleared on Aug 1, 2008 as substantially equivalent to K033200 (Applied Imaging Corp., 2004) after a 217-day review. Its family tree reaches back 1 generation to 2004. 7 later devices descend from it.
- Decided
- Aug 1, 2008
- Review
- 217 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033200 (2004). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK033200 ARIOLApplied Imaging Corp. · 2004 · Recalled
- This deviceK073677 Scanscope XT SystemAperio Technologies · 2008
- Descendant · cites it directly · 4 of its ownK111869 Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK141109 Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK122143 Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK260755 OptraSCAN SystemOptrascan, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK142965 Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111869Virtuoso System for Ihc PR (IE2)Ventana Medical Systems, Inc. · 2012 · cites it directly4descendants
- K141109Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · cites it directly1descendant
- K122143Virtuoso System for Ihc PR (1E2) Benchmark Ultra StainerVentana Medical Systems, Inc. · 2013 · 2 generations on1descendant
- K260755OptraSCAN SystemOptrascan, Inc. · 2026 · 2 generations on0descendants
- K142965Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033200 | ARIOL | Applied Imaging Corp. | 2004 | 1 |
| 0 (this device) | K073677 | Scanscope XT System | Aperio Technologies | 2008 | — |
| +1 | K111869 | Virtuoso System for Ihc PR (IE2) | Ventana Medical Systems, Inc. | 2012 | — |
| +1 | K141109 | Aperio Epathology Eihc Ivd System | Leica Biosystems Imaging, Inc. | 2014 | 1 |
| +2 | K122143 | Virtuoso System for Ihc PR (1E2) Benchmark Ultra Stainer | Ventana Medical Systems, Inc. | 2013 | — |
| +2 | K260755 | OptraSCAN System | Optrascan, Inc. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033200 | ARIOLSummary page 2…Predicate Device: Applied Imaging AriolTM with ER/PR Application Manufacturer: Applied Imaging Coporation Predicate Device k#: k033200 21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket n… | 2004 |
| † | K993957 | Dako Monoclonal Mouse Anti-Human Estrogen Receptor | 2000 |
| † | K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for… | 2002 |
What descends from it? (7)
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?
- Its one ancestor has a recall.
- Of its descendants, K111869 (Ventana Medical Systems, Inc., 2012) has gone furthest, with 4 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. 2008, 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 ScanScope® XT System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative…
Read the full statement (240 words)
The ScanScope® XT System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape.
The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded normal and neoplastic tissue.
The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
Note: The IHC ER and PR Image Analysis applications are an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of estrogen and progesterone receptor proteins. The accuracy of the test result depends upon 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 ER and PR reagent/kit used to assure the validity of the IHC ER and PR Image Analysis application assisted scores.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073677: Scanscope XT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073677
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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