510(k) · Cleared
ClearedOptraSCAN System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optrascan, Inc. · NOT Microscope, Automated, Image Analysis, Operator Intervention
Cleared on Jul 2, 2026 as substantially equivalent to K141109 (Leica Biosystems Imaging, Inc., 2014) after a 115-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jul 2, 2026
- Review
- 115 days
- Class
- Class II
- Product code
- NOT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K032113 (2003). 5 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 backK071128 Scanscope XT SystemAperio Technologies · 2007
- 1 generation backK141109 Aperio Epathology Eihc Ivd SystemLeica Biosystems Imaging, Inc. · 2014 · Recalled
- This deviceK260755 OptraSCAN SystemOptrascan, Inc. · 2026
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 | K071128 | Scanscope XT System | Aperio Technologies | 2007 | — |
| −1 | K141109 | Aperio Epathology Eihc Ivd System | Leica Biosystems Imaging, Inc. | 2014 | 1 |
| 0 (this device) | K260755 | OptraSCAN System | Optrascan, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 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.
- 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 |
|---|---|---|---|
| * | K141109 | Aperio Epathology Eihc Ivd SystemSummary page 5…Operator Intervention Predicate Device • Aperio ePathology eIHC IVD System, AT Turbo and CS2 models (K141109) INTENDED USE/INDICATIONS FOR USE The OptraSCAN System is an automated digital slide creation, management, viewing and analysis… | 2014 |
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 23 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2026, 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?
The OptraSCAN System is an automated digital slide creation, management, viewing and analysis system which consists of the OS-Ultra Scanner, Color Display Monitor (Model No. Dell U2424HE) and a Workstation, preinstalled with software to operate the scanner and the ImagePath application (Image Management software and HER2 Image Analysis Software). The OptraSCAN System is intended for in vitro diagnostic use as an aid to the pathologist in the review and…
Read the full statement (245 words)
The OptraSCAN System is an automated digital slide creation, management, viewing and analysis system which consists of the OS-Ultra Scanner, Color Display Monitor (Model No. Dell U2424HE) and a Workstation, preinstalled with software to operate the scanner and the ImagePath application (Image Management software and HER2 Image Analysis Software).
The OptraSCAN System is intended for in vitro diagnostic use as an aid to the pathologist in the review and semi-quantitative scoring of HER2 protein expression in scanned digital images obtained using OS-Ultra Scanner of slides prepared from formalin-fixed paraffin embedded (FFPE) breast tissue and stained with the Dako HercepTestTM.
The HER2 Image Analysis Software outputs the scores for individual Regions of Interest (ROIs) as well as the slide level score based on all the ROIs. The pathologist is responsible for making the final decision of the score, based on the output provided by the system. The OptraSCAN System software makes no independent interpretations of the data.
Note: The HER2 Image Analysis Software is an adjunctive computer-assisted methodology to assist qualified pathologists in HER2 scoring in breast cancer. The accuracy of the test result depends upon the quality of the immunohistochemical staining.
It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for use for the Dako HercepTestTM to assure the validity of the HER2 Image Analysis Software assisted HER2 score. The actual correlation of the Dako HercepTestTM to Herceptin® clinical outcome has not been established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260755: OptraSCAN System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260755
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026