FDA 510(k)

Ultrasound System SONIMAGE MX1

Número K: K220993 · 2022-06-23

Data da decisão2022-06-23

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ultrasound System SONIMAGE MX1 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 2022-06-23 under 510(k) number K220993. 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 MX1?

Ultrasound System SONIMAGE MX1 is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K220993.

When did Ultrasound System SONIMAGE MX1 receive FDA 510(k) clearance?

Ultrasound System SONIMAGE MX1 received FDA 510(k) clearance on 2022-06-23, under 510(k) number K220993.

Who is the listed applicant for Ultrasound System SONIMAGE MX1?

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 MX1?

The FDA product code for Ultrasound System SONIMAGE MX1 is IYN.

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Fonte oficial

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