# K122536: Amcad-UT Detection Model 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Lin & Associates, LLC
- Decided: Oct 3, 2013 after 409 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 6 generations back to K913770 (1991). 24 ancestors in all.
69 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 2.
- K050846: B-Cad System, Version 1.0, The Medipattern Corporation (2005) Summary page 2.
- K083423: Coloncad Api 3.1, Medicsight Plc (2011) Summary page 2.

## Most influential descendants
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K171070: WS80A Diagnostic Ultrasound System (2017), 42 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own

## Indications for use
AmCAD-UT® Detection 2.0 is a Windows-based computer-assisted detection (CADe) device intended to assist the medical professionals in analyzing thyroid ultrasound images of user-selected regions of interest (ROI). 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 Philips HDI5000 images of discrete thyroid nodules larger than 1cm, for which a biopsy has been recommended. The device performance has been validated on images collected from Philips HDI5000 with a 5-12MHz multi-frequency probe.

Source page: https://510kreport.com/device/K122536
Methodology: https://510kreport.com/methodology