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510(k) Data Aggregation
K Number
K220039Device Name
AutoSeg
Manufacturer
AI Medic Inc.
Date Cleared
2022-07-20
(196 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
AI Medic Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AutoSeg-H is medical imaging software that is intended to professionals with tools to aid them in reading, interpreting, reporting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).
AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:
- Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
- Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
- 4-Chamber Analysis: which is intended for automatic extraction of the left atrium, and right ventricle from CT.
Device Description
AutoSeg-H(V1.0.0.01) is software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. AutoSeg-H(V1.0.0.01) runs on Windows standalone installed on a commercial general-purpose Windows-compatible computer and accepts DICOM compliant medical images acquired from a CT. The AutoSeg-H is not connected to a PACS system directly but retrieves saved image data from a computer. Image data obtained from the computer are used for display, image processing, analysis, etc. AutoSeg-H cannot be used to interpret Mammography images.
The main functions of AutoSeg-H are shown below.
- Coronary Artery Analysis (CT) -
- Aortic Valve Analysis (CT) -
- -4-Chamber Analysis (CT)
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