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 · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Aug 14, 2009 as substantially equivalent to K032113 (Chroma Vision Medical Systems, Inc., 2003) and 1 other predicate after a 533-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Aug 14, 2009
- Review
- 533 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K032113 (2003). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- This deviceK080564 Scanscope XT SystemAperio Technologies · 2009
- Descendant · cites it directly · 2 of its ownK111543 Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK131140 Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014
Most influential descendants
Showing 3 of 3 · See all- K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011 · cites it directly2descendants
- K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015 · 2 generations on0descendants
- K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032113 | Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K080564 | Scanscope XT System | Aperio Technologies | 2009 | — |
| +1 | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| +2 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K032113 | Acis (Automated Cellular Imaging System)Summary page 2…510(k) Summary- ScanScope® XT System -RevJune 09 Page 1 of 7 a aperio Predicate Device K#: K032113 Predicate Device #2: Applied Imaging Ariol T M with HER2 Application Manufacturer: Appli… | 2003 |
| * | K031715 | Ariol Her-2/Neu IhcSummary page 2…e #2: Applied Imaging Ariol T M with HER2 Application Manufacturer: Applied Imaging Corporation Predicate Device K#: K031715 21 CFR 807.92(a)(4): Description of the device that is the subject of this pre-market notification: System.' The ScanS… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | 2011 | 2 |
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?
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. 2009, 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 ScanScope 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 HER2 Breast Tissue Tunable Image Analysis application is intended for use as an aid to the pathologist in the…
Read the full statement (263 words)
The ScanScope 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 HER2 Breast Tissue Tunable Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue.
The IHC HER2 Breast Tissue Tunable Image Analysis application is intended for use as an accessory to the Dako HercepTestTM to aid in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It 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 Breast Tissue Tunable Image Analysis application is 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 HER2 receptor protein. 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 HER2 reagent/kit used to assure the validity of the IHC HER2 Breast Tissue Tunable Image Analysis application assisted HER2/neu score. The actual correlation of the HER2 reagents/kits to Herceptin® clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080564: Scanscope XT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080564
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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