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510(k) Data Aggregation
K Number
K182165Device Name
Color Doppler Ultrasound System; Model: mEye1 and mEye2
Manufacturer
Date Cleared
2018-12-20
(132 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Well.D Medical Electronics Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.
Device Description
The Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the imaging operation modes of B, M, PWD and Color Doppler.
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