SonoBook Series Diagnostic Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

CHISON Medical Imaging Co., Ltd.

The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Sonobook Series Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK170374
510k NumberK170374
Device Name:SonoBook Series Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHISON Medical Imaging Co., Ltd. NO.228, ChangJiang East Road,Block 51 And 53, Phase 5 Industrial Park ShouFa Wuxi,  CN 214142
ContactQifei Liu
CorrespondentBob Leiker
Leiker Regulatory & Quality Consulting 4157 North Del Ray Ave Clovis,  CA  93619
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-07
Decision Date2017-06-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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06945121414166 K170374 000

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