# K170069: AmCAD-UV

- Pathway: 510(k) (Traditional)
- Applicant: Amcad Biomed Corporation
- Decided: Apr 26, 2017 after 107 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: 14 generations back to K935595 (1995). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132165: Qlab Quantification Software, Philips Ultrasound, Inc. (2013) Summary page 5.

## Indications for use
AmCAD-UV is a software device designed for classifying the ultrasonic color intensity data and allowing users to view classified color-coded signals, namely, primary pulsatile, secondary pulsatile, and unidentified signals of flow Doppler ultrasound images. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis but must not be used alone for primary diagnostic interpretation.

Source page: https://510kreport.com/device/K170069
Methodology: https://510kreport.com/methodology