FDA 510(k)

Imagio Ultrasound Imaging System

Número K: K182628 · 2019-03-05

RequerenteSeno Medical Instruments, Inc.

Data da decisão2019-03-05

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Imagio Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Seno Medical Instruments, Inc.. It received FDA 510(k) clearance on 2019-03-05 under 510(k) number K182628. 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 Imagio Ultrasound Imaging System?

Imagio Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2019-03-05. The listed applicant is Seno Medical Instruments, Inc.. The 510(k) number is K182628.

When did Imagio Ultrasound Imaging System receive FDA 510(k) clearance?

Imagio Ultrasound Imaging System received FDA 510(k) clearance on 2019-03-05, under 510(k) number K182628.

Who is the listed applicant for Imagio Ultrasound Imaging System?

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

What is the FDA product code for Imagio Ultrasound Imaging System?

The FDA product code for Imagio Ultrasound Imaging System is IYN.

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