ALPHAPOINT IMAGING SOFTWARE
RADLOGICS, INC.AlphaPoint Imaging Software is a tool that helps clinicians review and analyze CT chest images by providing segmentation and numerical analysis of tissue types. It assists in identifying different substances in the images and generates preliminary reports to support medical decision-making.
Intended Use
The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images to assist medical professionals in image analysis. It provides segmentation, Hounsfield numerical analysis, and substance indication. The user can verify and correct results and generate a findings report.
Technology
AlphaPoint integrates with PACS via DICOM to retrieve CT chest images, and applies segmentation and Hounsfield measurement algorithms to process images. The software is implemented in C++, C#, and Matlab and outputs preliminary findings reports back to PACS.
Performance
The software was verified and validated following company design controls and FDA software guidance. It passed DICOM compliance testing and underwent rigorous software verification including design reviews, code reviews, unit and system testing, with an independent validation engineer confirming it was ready for release.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/19/2012
2 months - 2
FDA Approval
4/13/2012
Other devices from RADLOGICS, INC.
- AIMI-Triage CXR PTX2020 • 510K
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