# The FDA's latest clearance of HER2 scoring software keeps the final score with the pathologist; the software makes no independent interpretation

Page: https://flyvolo.ai/en/changes/ev-20260702-pathologist-11
Date: 2026-07-02 · Stage: Constraint
Can this record move a task judgement? yes
Occupation: https://flyvolo.ai/en/careers/pathologist

## Scope

United States. The clearance documents say the system is intended as an aid to the pathologist in the review and semi-quantitative scoring of HER2 protein expression; that the pathologist is responsible for the final decision on the score, based on the system's output; and that the software makes no independent interpretations of the data. One device's cleared use; it says nothing about which laboratories use it or how accurate it is in practice.

## Source

- U.S. Food and Drug Administration — 510(k) K260755, OptraSCAN System (HER2 Image Analysis Software), clearance letter of 2 July 2026 — https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260755.pdf (primary source)

## What this means

In the US, scoring software is cleared only as an aid: the pathologist still decides the score that goes on the report.

## What it does not show yet

One device's clearance; it does not show how widely such tools are used.

## How to verify it yourself

Open FDA 510(k) K260755 and find "The pathologist is responsible for making the final decision of the score".


More: https://flyvolo.ai/llms.txt