Quantitative Total Extensible Imaging (QTxI)
AIQ Solutions, Inc.Quantitative Total Extensible Imaging (QTxI) is a software tool that helps medical professionals manage and evaluate digital medical images from CT and PET scans. It supports tasks such as storing, retrieving, and displaying images, as well as identifying and analyzing regions of interest (ROIs) in full or partial body scans with 3D visualization. This software aids clinicians by automating quantification and monitoring changes in imaging data to improve diagnostic and treatment decision workflows.
Intended Use
Software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including radiologists, oncologists, nuclear medicine physicians, medical imaging technologists, dosimetrists, and physicists. Supports DICOM CT and PET images for receiving, storing, retrieving, displaying, processing images, creating reports, image registration and fusion, ROI identification and contouring, quantitative/statistical analysis, and 3D interactive rendering.
Technology
Standalone software operating on Windows 7 or Windows 10 that receives, stores, retrieves, displays, processes DICOM CT and PET images. It performs image registration and fusion, identifies regions of interest (ROIs), and executes ROI contouring to permit quantitative and statistical analysis of partial or full body scans through registration to a template space. Includes a module (QTBI) specialized for automatic identification and measurement of hotspots on PET scans, supporting 3D interactive visualization of skeleton and highlighted ROIs.
Performance
Non-clinical performance bench tests and simulated clinical performance tests were conducted to verify software meets product performance and functional specifications, maintain data integrity for DICOM data, and ensures proper data capture, transmission, and storage. The device met all predetermined acceptance criteria for design verification and validation as specified by applicable standards and protocols.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/6/2017
8 months - 2
FDA Approval
7/23/2018
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