PixelShine
ALGOMEDICAPixelShine is a software application that improves the quality of CT images by reducing noise, making them clearer to assist radiologists and specialists in diagnosing patients. It connects to existing CT imaging systems, processes the images, and sends enhanced images back for review, facilitating better clinical decisions.
Intended Use
The AlgoMedica PixelShine System is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3.0 mm. The AlgoMedica PixelShine is not intended for use with or for diagnostic interpretation of mammography images.
Technology
PixelShine is a medical imaging application running on specified off-the-shelf PC hardware with Linux OS, performing noise reduction on CT DICOM images over a network using a non-linear filter. It operates independently as a DICOM device, receiving, processing, and sending enhanced CT images.
Performance
Performance validation was performed with phantom studies and image data comparisons. Non-clinical performance testing including unit integration, system-level, verification, and validation testing were all passed with satisfactory results.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/13/2016
3 months - 2
FDA Approval
9/19/2016
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