510(k) · Cleared
ClearedPhilips Herceptest Digital Score
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OEO Automated Digital Image Manual Interpretation Microscope
Cleared on Sep 19, 2013 as substantially equivalent to K111914 (Olympus America Inc. / Scientific Equipment Group, 2012) and 1 other predicate after a 259-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Sep 19, 2013
- Review
- 259 days
- Class
- Class II
- Product code
- OEO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032113 (2003). 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 backK071671 Scanscope XT SystemAperio Technologies · 2007
- 1 generation backK111914 Virtual Slide System, Olympus VS800 SystemOlympus America Inc. / Scientific Equipment Group · 2012
- This deviceK130021 Philips Herceptest Digital ScorePhilips Medical Systems Nederland B.V. · 2013
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 | K071671 | Scanscope XT System | Aperio Technologies | 2007 | — |
| −1 | K111914 | Virtual Slide System, Olympus VS800 System | Olympus America Inc. / Scientific Equipment Group | 2012 | — |
| 0 (this device) | K130021 | Philips Herceptest Digital Score | Philips Medical Systems Nederland B.V. | 2013 | — |
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 |
|---|---|---|---|
| * | K111914 | Virtual Slide System, Olympus VS800 SystemSummary page 1…Olympus Aperio Technologies 510(k) Number: K1 11914 K071671 Classification Name:… | 2012 |
| * | K071671 | Scanscope XT SystemSummary page 1…pus Aperio Technologies 510(k) Number: K1 11914 K071671 Classification Name: Immunolhistochemistry reagents and kits Cl… | 2007 |
| † | P980018 | Dako Herceptest | 1998 |
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 10 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
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. 2013, 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 Philips HER2/neu IHC Digital Manual Read 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 Philips HER2/neu IHC Digital Manual Read is based on the Philips Digital Pathology Solution platform, which is an automated digital slide creation, management, viewing and analysis…
Read the full statement (235 words)
The Philips HER2/neu IHC Digital Manual Read 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 Philips HER2/neu IHC Digital Manual Read is based on the Philips Digital Pathology Solution platform, which is an automated digital slide creation, management, viewing and analysis system.
The Philips HER2/neu IHC Digital Manual Read is intended for use as an accessory to the Dako HercepTest to aid in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTest it is indicated for use as an aid in the assessment of breast cancer patients from whom HERCEPTIN® (Trastuzumab), PERJETA® (Pertuzumab) or KADCYLA® (Ado-Trastuzumab Emtansine) treatment is being considered. Note: The actual correlation of the Dako HercepTest to Herceptin®, Perjeta®, or Kadcyla®, clinical outcome has not been established.
Note: The Philips HER2/neu IHC Digital Manual Read is for evaluation of digital images of immunohistochemically stained slides that would otherwise be appropriate for manual visualization by conventional microscopy. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for Dako HercepTest to assure the validity of the scores obtained using Philips HER2/neu IHC Digital Manual Read.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130021: Philips Herceptest Digital Score.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130021
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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