FDA 510(k)

SonoVision 超聲影像系統

K 號：K192388 · 2020-03-12

申請人Tissue Differentiation Intelligence, LLC

決定日期2020-03-12

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：IYN）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：IYN）

官方來源