# K260755: OptraSCAN System

- Pathway: 510(k) (Traditional)
- Applicant: Optrascan, Inc.
- Decided: Jul 2, 2026 after 115 days
- Product code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032113 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141109: Aperio Epathology Eihc Ivd System, Leica Biosystems Imaging, Inc. (2014) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K260755
Methodology: https://510kreport.com/methodology