FDA 510(k)

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

K-Number: K220983 · 2022-11-11

Decision Date2022-11-11

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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