FDA 510(k)

ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system

Número K: K261272 · 2026-07-23

RequerenteEsonic Technology (Wuhan) Co., Ltd.

Data da decisão2026-07-23

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system is the device name listed in this FDA 510(k) record. The listed applicant is Esonic Technology (Wuhan) Co., Ltd.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261272. 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 ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system?

ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Esonic Technology (Wuhan) Co., Ltd.. The 510(k) number is K261272.

When did ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system receive FDA 510(k) clearance?

ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261272.

Who is the listed applicant for ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system?

The FDA 510(k) record lists Esonic Technology (Wuhan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system?

The FDA product code for ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system is IYN.

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Outros registros que listam Esonic Technology (Wuhan) Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: IYN)

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