FDA 510(k)

ImSonic TR-1超声波脉冲多普勒成像系统

K号: K220983 · 2022-11-11

决定日期2022-11-11

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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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