ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K-Number: K220983 · 2022-11-11
ApplicantImsonic Medical China, Inc.
Decision Date2022-11-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System is a medical device manufactured by Imsonic Medical China, Inc.. It received FDA 510(k) clearance on 2022-11-11 under approval 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. It is manufactured by Imsonic Medical China, Inc.. The 510(k) number is K220983.
When was ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System approved by the FDA?
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System received FDA 510(k) clearance on 2022-11-11, under approval number K220983.
What company makes ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System?
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System is manufactured by Imsonic Medical China, Inc..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.