FDA 510(k)

ImSonic TR-1 超聲波脈沖多普勒成像系統

K 號：K220983 · 2022-11-11

決定日期2022-11-11

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Imsonic Medical China, Inc.. It received FDA 510(k) clearance on 2022-11-11 under 510(k) number K220983. 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 ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System?

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System is a medical device that received FDA 510(k) clearance on 2022-11-11. The listed applicant is Imsonic Medical China, Inc.. The 510(k) number is K220983.

When did ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System receive FDA 510(k) clearance?

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System received FDA 510(k) clearance on 2022-11-11, under 510(k) number K220983.

Who is the listed applicant for ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System?

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

What is the FDA product code for ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System?

The FDA product code for ImSonic TR-1 Ultrasonic Pulsed Doppler 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