FDA 510(k)

PathPresenter Clinical Viewer

Номер K: K250968 · 2025-06-20

Дата решения2025-06-20

Код продуктаQKQ

Консультативный комитетPA

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: QKQ)

K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLC K243391AISight DxPathAI, Inc.K250414CaloPixTribun Health K242244Viewer+Lumea, Inc.

Официальный источник

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