510(k) · Cleared
ClearedOmnyx Idp for HER2 Manual Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnyx, LLC · OEO Automated Digital Image Manual Interpretation Microscope
Cleared on Apr 1, 2014 as substantially equivalent to K071671 (Aperio Technologies, 2007) and 1 other predicate after a 344-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Apr 1, 2014
- Review
- 344 days
- Class
- Class II
- Product code
- OEO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032113 (2003). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- 2 generations backK080564 Scanscope XT SystemAperio Technologies · 2009
- 1 generation backK111543 Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011
- This deviceK131140 Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032113 | Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2003 | — |
| −2 | K080564 | Scanscope XT System | Aperio Technologies | 2009 | — |
| −1 | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| 0 (this device) | 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 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K071671 | Scanscope XT SystemSummary page 5…nual Read of the Aperio ScanScope XT System Virtuoso"' IHC HER2 Comparators Dhiia HERZ Application (K071671) (K111543) indicated for use as an a… | 2007 |
| * | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5)Summary page 4…perin ScanScope XT System VirtuosTm IlIC HER2 Comparators Digital HER2 Application (K(071671) (K111543) Intended use The Omnyx Manual Read of The ScanScope system is an This device is intended for in vitro… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 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. 2014, 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 Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for in vitro diagnostic use as an aid to pathology professionals for creating, managing, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections stained with the Dako HercepTest. The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for use as an…
Read the full statement (129 words)
The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for in vitro diagnostic use as an aid to pathology professionals for creating, managing, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections stained with the Dako HercepTest.
The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in digital images of FFPE breast cancer tissue immunohistochemically stained with the Dako HercepTest and viewed on a computer monitor.
The Dako HercepTest is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131140: Omnyx Idp for HER2 Manual Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131140
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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