PIUR tUS inside
PIUR Imaging GmbHPIUR tUS inside is a medical device that enhances standard 2D ultrasound devices by generating three-dimensional (3D) tomographic ultrasound volumes of the thyroid. It assists physicians in diagnosing thyroid nodules by providing volumetric information, segmentation, and quantification of sonographic characteristics. This device operates directly on compatible ultrasound scanners, integrating sensor data to create 3D images that support clinical decision-making as an add-on to regular ultrasound imaging.
Intended Use
PIUR tUS inside System 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. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules. It is for use on adults aged 22 and older and acts as an add-on to regular 2D ultrasound imaging.
Technology
This system combines 2D ultrasound image streams and sensor (IMU) data from the ultrasound transducer to generate tomographic 3D ultrasound volumes. It operates directly on compatible GE Healthcare ultrasound scanners and uses computer vision, machine learning, and pattern recognition for image reconstruction, segmentation, and quantification of thyroid nodules. The device uses Bluetooth to connect the PIUR Sensor to track probe movement and employs volume compounding and semi-automatic segmentation algorithms.
Performance
Performance validation included software verification and validation demonstrating the system meets all design requirements. Electrical safety and electromagnetic compatibility testing complied with IEC standards. A white-noise test verified that the wireless equipment does not degrade ultrasound image quality. Overall, the device showed substantial equivalence in performance and safety to the predicate device K240036.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/19/2025
4 months - 2
FDA Approval
6/30/2025
Other devices from PIUR Imaging GmbH
- PIUR tUS Infinity2024 • 510K
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