ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

System, Imaging, Pulsed Doppler, Ultrasonic

ImSonic Medical China, INC.

The following data is part of a premarket notification filed by Imsonic Medical China, Inc. with the FDA for Imsonic Tr-1 Ultrasonic Pulsed Doppler Imaging System.

Pre-market Notification Details

Device IDK220983
510k NumberK220983
Device Name:ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant ImSonic Medical China, INC. No. 168 Yuanfeng Road Kunshan,  CN 215300
ContactXiaohui Hao
CorrespondentXiaohui Hao
ImSonic Medical China, INC. No. 168 Yuanfeng Road Kunshan,  CN 215300
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-11-11

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