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510(k) Data Aggregation
K Number
K200356Device Name
MEDO ARIA
Manufacturer
Date Cleared
2020-06-11
(119 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Medo.ai
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.
Device Description
MEDO ARIA is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of developmental hip dysplasia (DDH) of pediatric patients (e.g., ages 0 to 12 months). It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for hip images. MEDO ARIA Software takes as an input imported Digital Imaging and Communications in Medicine (DICOM) images from ultrasound scanners and allows users to upload, browse, and view images, measure alpha angle and acetabular coverage, and manipulate 2D and 3D infant hip ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing pediatric ultrasound hip images, placing landmarks, and creating reports.
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