# K203555: AmCAD-UT

- Pathway: 510(k) (Traditional)
- Applicant: Amcad Biomed Corporation
- Decided: Sep 8, 2021 after 275 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: 8 generations back to K913770 (1991). 26 ancestors in all.
2 later devices descend 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)
- K180006: AmCAD-UT Detection 2.2, Amcad Biomed Corporation (2018) Summary page 5.

## Most influential descendants
- K240036: PIUR tUS Infinity (2024), 1 descendant of its own
- K250484: PIUR tUS inside (2025), 0 descendants of its own

## Indications for use
AmCAD-UT is a Windows-based computer-aided detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA-cleared ultrasound systems. The region of interest (ROI) of a user-selected thyroid nodule is defined by users or suggested by an AI contouring algorithm. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than Icm, for which a biopsy recommendation is required.

Source page: https://510kreport.com/device/K203555
Methodology: https://510kreport.com/methodology