Source document or public record

FDA 510(k) K250968 — PathPresenter Clinical Viewer

FDA 510(k) index record K250968. Device: PathPresenter Clinical Viewer. Applicant as listed: Pathpresenter Corporation. Decision date: 2025-06-20.

OtherU.S. Food and Drug Administration (FDA)2025-06-20

Source

"device_name": "PathPresenter Clinical Viewer"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K250968.

Device name: PathPresenter Clinical Viewer. Applicant as listed: Pathpresenter Corporation.

Decision date: 2025-06-20. Decision wording: Substantially Equivalent.

Product code: QKQ. Regulation: 21 CFR 864.3700. Medical specialty: Pathology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

Interested in these solutions?

Submit a sourcing request with the assays, volumes, and timeline of your own project.