510(k) · Cleared
ClearedPathiam System with Iscan for P53 and KI-67
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioimagene, Inc. · NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Cleared on Oct 27, 2010 as substantially equivalent to K062428 (Tripath Imaging, Inc., 2006) and 1 other predicate after a 449-day review. Its family tree reaches back 1 generation to 2006. 7 later devices descend from it.
- Decided
- Oct 27, 2010
- Review
- 449 days
- Class
- Class II
- Product code
- NQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K053520 (2006). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK053520 Ventana Image Analysis System, Model KI-67Tripath Imaging, Inc. · 2006
- This deviceK092333 Pathiam System with Iscan for P53 and KI-67Bioimagene, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK111755 Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK111543 Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK111872 Virtuoso System for Ihc P53 (DO-7)Ventana Medical Systems, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK140957 Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK131140 Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111755Virtuoso System for Ihc KI-67 (30-9)Ventana Medical Systems, Inc. · 2012 · cites it directly2descendants
- K111543Virtuoso (TM) System for Ihc HER2 (4B5)Ventana Medical Systems, Inc. · 2011 · cites it directly2descendants
- K111872Virtuoso System for Ihc P53 (DO-7)Ventana Medical Systems, Inc. · 2012 · cites it directly1descendant
- K140957Genasis Hipath Ihc FamilyApplied Spectral Imaging, Ltd. · 2015 · 2 generations on0descendants
- K131140Omnyx Idp for HER2 Manual ApplicationOmnyx, LLC · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053520 | Ventana Image Analysis System, Model KI-67 | Tripath Imaging, Inc. | 2006 | — |
| 0 (this device) | K092333 | Pathiam System with Iscan for P53 and KI-67 | Bioimagene, Inc. | 2010 | — |
| +1 | K111755 | Virtuoso System for Ihc KI-67 (30-9) | Ventana Medical Systems, Inc. | 2012 | — |
| +1 | K111543 | Virtuoso (TM) System for Ihc HER2 (4B5) | Ventana Medical Systems, Inc. | 2011 | — |
| +1 | K111872 | Virtuoso System for Ihc P53 (DO-7) | Ventana Medical Systems, Inc. | 2012 | — |
| +2 | K140957 | Genasis Hipath Ihc Family | Applied Spectral Imaging, Ltd. | 2015 | — |
| +2 | K131140 | Omnyx Idp for HER2 Manual Application | Omnyx, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 NQN? 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 |
|---|---|---|---|
| * | K062428 | Ventana Image Analysis System, Model ViasSummary page 3…a qualified pathologist. The pathologist must verify agreement with the PATHIAM score. Predicate Device: Tripath Imaging, Inc. Ventana® Image Analysis System (VIASTmI) K062428 - VWAS p53 application K053520 - VWAS Ki-67 application Regulation: 21 CFR §864.1860, Inmmunohistochemistry Reagents and Kits Pro… | 2006 |
| * | K053520 | Ventana Image Analysis System, Model KI-67Summary page 3…athologist must verify agreement with the PATHIAM score. Predicate Device: Tripath Imaging, Inc. Ventana® Image Analysis System (VIASTmI) K062428 - VWAS p53 application K053520 - VWAS Ki-67 application Regulation: 21 CFR §864.1860, Inmmunohistochemistry Reagents and Kits Product Code: NQN Panel: Pathology… | 2006 |
What descends from it? (7)
3 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K111755 (Ventana Medical Systems, Inc., 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NQN devicesNQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NQN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NQN
427in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQN
1in 2023
MAUDE reports naming product code NQN, 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 | — | 1 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 427 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is intended for in vitro diagnostic (IVD) use. The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores. This instrument is intended for in-vitro diagnostic use only with those assays for which it has received FDA clearance. The iScan Slide…
Read the full statement (513 words)
This device is intended for in vitro diagnostic (IVD) use.
The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores.
This instrument is intended for in-vitro diagnostic use only with those assays for which it has received FDA clearance.
The iScan Slide Scanner System is designed to be used to scan and digitize microscope slides, and compress and view digitized images of microscope slides.
If the Scanner is used in any way not specified in this manual, the protection provided by the equipment may be compromised.
This device is intended for in vitro diagnostic (IVD) use.
The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores.
The Ki-67 application is intended as an aid to the pathologist to quantify the percentage of positively stained nuclei in formalin-fixed paraffin embedded normal and neoplastic breast tissue specimens immunohistochemically stained with Dako mouse monoclonal anti-human Ki-67 antigen, clone MI131 visualized with DAB chromogen as specified in the instructions for these reagents. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for Dako Ki-67 to assure the validity of the PATHIAM-assisted Ki-67 assessment.
Ki-67 results provided by the PATHIAM System are indicated for use to assess proliferative activity when used with in vitro diagnostic reagents marketed for this indication. interpretation should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The pathologist must verify agreement with the PATHIAM score.
This device is intended for in vitro diagnostic (IVD) use.
The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores.
The p53 application is intended for use as an aid to the pathologist to quantify the percentage of positively stained nuclei in formialin fixed paraffin embedded breast tissue specimens stained with Dako mouse monoclonal anti-human p53 antibody, clone DO7and visualized with DAB. chromogen, to detect both wild-type and mutant p53, a nuclear protein, as specified in the instructions for these reagents. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for Dako p53 to assure the validity of the PATHIAM-assisted p53 assessment.
The p53 results provided by the PATHIAM System are indicated for use for the identification of p53 accumulation in human neoplasias when used with IVD reagents marketed for this indication. Interpretation should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The pathologist must verify agreement with the PATHIAM score.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092333 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092333: Pathiam System with Iscan for P53 and KI-67.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092333
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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