# K240036: PIUR tUS Infinity

- Pathway: 510(k) (Traditional)
- Applicant: Piur Imaging GmbH
- Decided: Sep 20, 2024 after 259 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913770 (1991). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203555: AmCAD-UT, Amcad Biomed Corporation (2021) Summary page 5.

## Most influential descendants
- K250484: PIUR tUS inside (2025), 0 descendants of its own

## Indications for 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. 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).

Source page: https://510kreport.com/device/K240036
Methodology: https://510kreport.com/methodology