FDA 510(k)

ソノビジョン超音波画像システム

K番号: K192388 · 2020-03-12

申請者Tissue Differentiation Intelligence, LLC

決定日2020-03-12

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

SonoVision Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Differentiation Intelligence, LLC. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K192388. 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 SonoVision Ultrasound Imaging System?

SonoVision Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Tissue Differentiation Intelligence, LLC. The 510(k) number is K192388.

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

SonoVision Ultrasound Imaging System received FDA 510(k) clearance on 2020-03-12, under 510(k) number K192388.

Who is the listed applicant for SonoVision Ultrasound Imaging System?

The FDA 510(k) record lists Tissue Differentiation Intelligence, LLC as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for SonoVision 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）

公式ソース