FDA 510(k)

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Número K: K262548 · 2026-09-25

Data da decisão2026-09-25

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound, LLC. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K262548. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Philips Ultrasound, LLC. The 510(k) number is K262548.

When did EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System receive FDA 510(k) clearance?

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2026-09-25, under 510(k) number K262548.

Who is the listed applicant for EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

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

What is the FDA product code for EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System?

O código de produto da FDA para o Sistema de Ultrassonografia Diagnóstica EPIQ Inspira Series; Série Diagnóstica Affiniti é IYN.

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Outros registros que listam Philips Ultrasound, LLC como candidato(a)

K262311Alturion Series Diagnostic Ultrasound System K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System K260667Alturion Series Diagnostic Ultrasound System K260123EPIQ Series Diagnostic Ultrasound System K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems K252558Lumify Diagnostic Ultrasound System

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