PIUR tUS Infinity

K240036QIH9/20/2024

Applicant

PIUR Imaging GmbH

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. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules.

Indications for Use

PIUR TUS Infinity may be used on any adult patient aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply. The PIUR TUS Infinity acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging. PIUR TUS Infinity device is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).

Predicate Devices