510(k) · Cleared
ClearedVirtual Slide System, Olympus VS800 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America Inc. / Scientific Equipment Group · OEO Automated Digital Image Manual Interpretation Microscope
Cleared on Aug 21, 2012 as substantially equivalent to K071671 (Aperio Technologies, 2007) after a 412-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Aug 21, 2012
- Review
- 412 days
- Class
- Class II
- Product code
- OEO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032113 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- 1 generation backK071671 Scanscope XT SystemAperio Technologies · 2007
- This deviceK111914 Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group · 2012
- Descendant · cites it directly · 0 of its ownK130021 Philips Herceptest Digital ScorePhilips Medical Systems Nederland B.V. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130021Philips Herceptest Digital ScorePhilips Medical Systems Nederland B.V. · 2013 · cites it directly0descendants
View 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 | K071671 | Scanscope XT System | Aperio Technologies | 2007 | — |
| 0 (this device) | K111914 | Virtual Slide System, Olympus VS800 System | Olympus America Inc. / Scientific Equipment Group | 2012 | — |
| +1 | K130021 | Philips Herceptest Digital Score | Philips Medical Systems Nederland B.V. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K071671 | Scanscope XT SystemSummary page 2…1/8 3 Predicate Device Information Device Name 510(k) No. Manufacturer ScanScope XT System K071671 Aperic Technologies, Inc. 4 Device Description The VS800 System is an automated digital slide creation, management and… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130021 | Philips Herceptest Digital Score | 2013 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130021 (Philips Medical Systems Nederland B.V., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071671.
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. 2012, 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 VS800 system is an automated digital slide creation, management, and viewing 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 VS800HER2 Manual Read (MR) of digital slide application is intended for use as an aid to the pathologist in the detection and…
Read the full statement (219 words)
The VS800 system is an automated digital slide creation, management, and viewing 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 VS800HER2 Manual Read (MR) of digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue IHC stained for HER2 receptors on a computer monitor. HER2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer-
The VS800HER2 MR of digital slide application is intended for use as an accessory to the DakoHercepTest to aid the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor. When used with the Dako Hercep Test, 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 Hercep Test to the Herceptin® clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111914: Virtual Slide System, Olympus VS800 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111914
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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