Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Sup

System, Imaging, Pulsed Doppler, Ultrasonic

Edan Instruments, Inc.

The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Diagnostic Ultrasound System, Models: Acclarix Ax3, Acclarix Ax3 Exp, Acclarix Ax3 Super, Acclarix Ax25, Acclarix Ax28, Acclarix Ax2, Acclarix Ax2 Exp, Acclarix Ax2 Super, Acclarix Ax15, Acclarix Ax18, Acclarix Lx3, Acclarix Lx3 Exp, Acclarix Lx3 Sup.

Pre-market Notification Details

Device IDK202856
510k NumberK202856
Device Name:Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Sup
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen,  CN 518122
ContactYing Dai
CorrespondentYing Dai
Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen,  CN 518122
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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