FDA 510(k)

Imagio 超声成像系统

K号: K182628 · 2019-03-05

决定日期2019-03-05

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

相关器械（代码：IYN）

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器械摘要

常见问题

相关临床试验

相关器械（代码：IYN）

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