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 · OEO Automated Digital Image Manual Interpretation Microscope
Cleared on Dec 28, 2007 as substantially equivalent to K032113 (Chroma Vision Medical Systems, Inc., 2003) after a 192-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it.
- Decided
- Dec 28, 2007
- Review
- 192 days
- Class
- Class II
- Product code
- OEO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032113 (2003). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- This deviceK071671 Scanscope XT SystemAperio Technologies · 2007
- Descendant · cites it directly · 1 of its ownK111914 Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group · 2012
- Descendant · cites it directly · 0 of its ownK131140 Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014
- Descendant · cites it directly · 0 of its ownK130021 Philips Herceptest Digital ScorePhilips Medical Systems Nederland B.V. · 2013
- Descendant · cites it directly · 0 of its ownK080254 Scanscope XT SystemAperio Technologies · 2008
Most influential descendants
Showing 4 of 4 · See all- K111914Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group · 2012 · cites it directly1descendant
- K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014 · cites it directly0descendants
- K130021Philips Herceptest Digital ScorePhilips Medical Systems Nederland B.V. · 2013 · cites it directly0descendants
- K080254Scanscope XT SystemAperio Technologies · 2008 · cites it directly0descendants
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) | K071671 | Scanscope XT System | Aperio Technologies | 2007 | — |
| +1 | K111914 | Virtual Slide System, Olympus VS800 System | Olympus America Inc. / Scientific Equipment Group | 2012 | — |
| +1 | K131140 | Omnyx Idp for HER2 Manual Application | Omnyx, LLC | 2014 | — |
| +1 | K130021 | Philips Herceptest Digital Score | Philips Medical Systems Nederland B.V. | 2013 | — |
| +1 | K080254 | Scanscope XT System | Aperio Technologies | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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? (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 |
|---|---|---|---|
| * | K032113 | Acis (Automated Cellular Imaging System)Summary page 2…ar Imaging System ("ACIS") and ACIS HER2 software application Manufacturer: ChromaVision Medical Systems, Inc. Predicate Device k#: k032113 21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification: System: The ScanScope ® Sys… | 2003 |
| † | P980018 | Dako Herceptest | 1998 |
What descends from it? (4)
4 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?
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. 2007, 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 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 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection…
Read the full statement (228 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 Manual Read of Digital Slides application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. HER-2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
The IHC HER2 Manual Read of Digital Slides application is intended for use as an accessory to the Dako HercepTest T M to aid the pathologist in the detection and semi-quantitative measurement of HER-2/neu (c-erbB-2) by manual examination of the digital slide of formnalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTestTM, 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 actual correlation of the Dako HercepTest T M to Herceptin® clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071671: 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/K071671
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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