PIUR tUS inside

PIUR tUS inside is a computer-aided detection device that enhances standard ultrasound systems by converting 2D ultrasound images into 3D tomographic volumes for analysis of thyroid and thyroid nodules. It assists physicians in image documentation, analysis, and reporting by providing quantification and visualization of nodule characteristics, and is intended for adults aged 22 and older as an add-on to regular 2D ultrasound imaging, not as a standalone diagnostic tool.

The device uses an inertial measurement unit (IMU) built into the PIUR Sensor to track transducer orientation during freehand ultrasound sweeps, transmitting data wirelessly via Bluetooth. It shares the same volume compounding, lobe/nodule segmentation, and volume calculation algorithms with its predicate device. The main difference is that PIUR tUS inside accesses the image stream directly through a software interface on compatible GE ultrasound systems (LOGIQ E10 and LOGIQ E10s/Fortis), whereas the predicate uses an Infinity Box and WiFi connection, but this does not affect performance as the image data remains identical.

ISO 13485:2016 (quality management), ISO 14971:2019 (risk management), IEC 62366-1:2015 (usability), IEC 62304:2015 (software lifecycle), IEC 82304-1:2016 (health software safety), IEC 60601-1:2013 and IEC 60601-1-2:2014 (medical electrical equipment and electromagnetic compatibility), IEC 60601-2-37:2016 (ultrasonic diagnostic equipment), NEMA PS 3.1-3.20:2023 (DICOM), and FDA guidance on cybersecurity and computer-assisted detection devices.

PIUR tUS inside shares identical indications for use, same core algorithms for volume compounding and nodule segmentation, equivalent functional capabilities for 3D reconstruction and quantification, and the same DICOM compliance and output formats as predicate K240036 (PIUR tUS Infinity). Although the image retrieval interface differs (direct software interface versus Infinity Box), this architectural change does not alter image data or performance characteristics. Performance testing, software verification/validation, and safety testing all demonstrated the subject device meets design requirements identically to the predicate, with no unacceptable risks, establishing equivalence in intended use, technological characteristics, safety, and performance.