510(k) · Cleared
ClearedPathiam Imaging Software for HER2/Neu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioimagene, Inc. · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Feb 20, 2007 as substantially equivalent to K032113 (Chroma Vision Medical Systems, Inc., 2003) after a 159-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.
- Decided
- Feb 20, 2007
- Review
- 159 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032113 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK032113 Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2003
- This deviceK062756 Pathiam Imaging Software for HER2/NeuBioimagene, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK080910 Pathiam System for HER2/Neu Immunohistochemistry Reagents & KitsBioimagene, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K080910Pathiam System for HER2/Neu Immunohistochemistry Reagents & KitsBioimagene, Inc. · 2009 · 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) | K062756 | Pathiam Imaging Software for HER2/Neu | Bioimagene, Inc. | 2007 | — |
| +1 | K080910 | Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits | Bioimagene, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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…n established. Predicate Devices: Software Her2/neu application of ChromaVision Medical Systems, Inc. Automated Cellular Imaging System (ACIS) for Her2/neu, K032113 Performance a. Between laboratory reproducibility: PATHIAM software was tested by three different pathologists, who a… | 2003 |
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 |
|---|---|---|---|
| K080910 | Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits | 2009 | 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?
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. 2007, 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?
Biolmagene PATHIAM is intended for use as an accessory to the Dako HercepTest® to aid a pathologist in semi-quantitative measurement of HER2/neu (c-erbB-2) in Formalin-fixed, paraffin-embedded breast cancer tissue.
When used with the Dako HercepTest it is indicated 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 to Herceptin clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062756 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062756: Pathiam Imaging Software for HER2/Neu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062756
Report an extraction error
Are you the manufacturer?
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