FDA 510(k)

イマジオ超音波画像システム

K番号: K182628 · 2019-03-05

決定日2019-03-05

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

関連機器（コード：IYN）

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医療機器の概要

よくある質問

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関連機器（コード：IYN）

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