# K180867: AmCAD-UO

- Pathway: 510(k) (Traditional)
- Applicant: Amcad Biomed Corporation
- Decided: Dec 28, 2018 after 270 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: 12 generations back to K913770 (1991). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141745: Iqqa-Bodyimaging Software, Edda Technology (2014) Summary page 6.

## Indications for use
AmCAD-UO is a PC-based, self-contained, non-invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA-cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state.

Source page: https://510kreport.com/device/K180867
Methodology: https://510kreport.com/methodology