Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

System, Imaging, Pulsed Echo, Ultrasonic

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Acclarix Ax4 Diagnostic Ultrasound System / Acclarix Lx4 Diagnostic Ultrasound System.

Pre-market Notification Details

Device IDK190186
510k NumberK190186
Device Name:Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
ContactMelody Huang
CorrespondentMelody Huang
Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen,  CN 518122
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-01
Decision Date2019-03-28
Summary:summary

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