PIUR tUS Infinity
PIUR Imaging GmbHPIUR tUS Infinity is a computer-aided detection system that assists medical professionals by analyzing ultrasound images of the thyroid and thyroid nodules. It uses AI and machine learning algorithms to create 3D volume reconstructions from 2D ultrasound images, allowing quantification and visualization of thyroid nodules to aid diagnosis. The system integrates seamlessly with FDA-cleared ultrasound equipment and produces reports to support clinical decisions.
Intended Use
PIUR tUS Infinity is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting.
Technology
The device uses computer vision and machine learning algorithms to generate 3D volumetric reconstructions from 2D ultrasound images. It includes hardware components (Infinity Box and Infinity Sensor) that capture image data and transducer orientation to build 3D models for analysis of thyroid nodules.
Performance
Performance testing validated non-inferiority of volume measurement and ACR TI-RADS classification compared to conventional 2D ultrasound, including multicenter clinical studies and software validation. Safety and compatibility with ultrasound imaging were confirmed with electrical and EMC testing.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/5/2024
8 months - 2
FDA Approval
9/20/2024
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