FDA 510(k)

X1-FFR

Número K: K251355 · 2025-10-17

Data da decisão2025-10-17

Código do produtoQHA

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

X1-FFR is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251355. The device is classified under product code QHA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the X1-FFR?

X1-FFR is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Spectrawave, Inc.. The 510(k) number is K251355.

When did X1-FFR receive FDA 510(k) clearance?

X1-FFR received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251355.

Who is the listed applicant for X1-FFR?

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

What is the FDA product code for X1-FFR?

The FDA product code for X1-FFR is QHA.

Outros registros que listam Spectrawave, Inc. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253101HyperVue™ Imaging System - Integrated K251198HyperVue™ Software K243016Starlight Imaging Catheter K230691HyperVue™ Imaging System K221257SpectraWAVE Imaging System

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Fonte oficial

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