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FDA 510(k)

PathPresenter Clinical Viewer

K-Number: K250968 · 2025-06-20

ApplicantPathpresenter Corporation
Decision Date2025-06-20
Product CodeQKQ
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PathPresenter Clinical Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Pathpresenter Corporation. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250968. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PathPresenter Clinical Viewer?

PathPresenter Clinical Viewer is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Pathpresenter Corporation. The 510(k) number is K250968.

When did PathPresenter Clinical Viewer receive FDA 510(k) clearance?

PathPresenter Clinical Viewer received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250968.

Who is the listed applicant for PathPresenter Clinical Viewer?

The FDA 510(k) record lists Pathpresenter Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PathPresenter Clinical Viewer?

The FDA product code for PathPresenter Clinical Viewer is QKQ.

Related Devices (Code: QKQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLCK243391AISight DxPathAI, Inc.K250414CaloPixTribun Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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