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FDA 510(k)

Color Doppler Ultrasound System; Model: mEye1 and mEye2

K-Number: K182165 · 2018-12-20

ApplicantShenzhen Well.D Medical Electronics Co., Ltd.
Decision Date2018-12-20
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is a medical device manufactured by Shenzhen Well.D Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-12-20 under approval number K182165. 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 Color Doppler Ultrasound System; Model: mEye1 and mEye2?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is a medical device that received FDA 510(k) clearance on 2018-12-20. It is manufactured by Shenzhen Well.D Medical Electronics Co., Ltd.. The 510(k) number is K182165.

When was Color Doppler Ultrasound System; Model: mEye1 and mEye2 approved by the FDA?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 received FDA 510(k) clearance on 2018-12-20, under approval number K182165.

What company makes Color Doppler Ultrasound System; Model: mEye1 and mEye2?

Color Doppler Ultrasound System; Model: mEye1 and mEye2 is manufactured by Shenzhen Well.D Medical Electronics Co., Ltd..

What is the FDA product code for Color Doppler Ultrasound System; Model: mEye1 and mEye2?

The FDA product code for Color Doppler Ultrasound System; Model: mEye1 and mEye2 is IYN.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07613918 Brain Blood Flow and Cerebral Autoregulation Monitoring in Critically Ill Children NOT_YET_RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED

Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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.

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