FDA 510(k)

EchoNext

Número K: K260332 · 2026-06-08

Data da decisão2026-06-08

Código do produtoQXO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

EchoNext is the device name listed in this FDA 510(k) record. The listed applicant is Pathwai, Inc.. It received FDA 510(k) clearance on 2026-06-08 under 510(k) number K260332. The device is classified under product code QXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EchoNext?

EchoNext is a medical device that received FDA 510(k) clearance on 2026-06-08. The listed applicant is Pathwai, Inc.. The 510(k) number is K260332.

When did EchoNext receive FDA 510(k) clearance?

EchoNext received FDA 510(k) clearance on 2026-06-08, under 510(k) number K260332.

Who is the listed applicant for EchoNext?

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

What is the FDA product code for EchoNext?

The FDA product code for EchoNext is QXO.

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