FDA 510(k)

Ultrasound System SONIMAGE HS1

Número K: K162065 · 2016-10-19

Data da decisão2016-10-19

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ultrasound System SONIMAGE HS1 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K162065. 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 Ultrasound System SONIMAGE HS1?

Ultrasound System SONIMAGE HS1 is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K162065.

When did Ultrasound System SONIMAGE HS1 receive FDA 510(k) clearance?

Ultrasound System SONIMAGE HS1 received FDA 510(k) clearance on 2016-10-19, under 510(k) number K162065.

Who is the listed applicant for Ultrasound System SONIMAGE HS1?

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

What is the FDA product code for Ultrasound System SONIMAGE HS1?

The FDA product code for Ultrasound System SONIMAGE HS1 is IYN.

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

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Dispositivos Relacionados (Código: IYN)

Fonte oficial

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