# K162574: AmCAD-US

- Pathway: 510(k) (Traditional)
- Applicant: Amcad Biomed Corporation
- Decided: May 30, 2017 after 257 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: 1 generation back to K021966 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Indications for use
AmCAD-US is a software device intended to visualize and analyze the statistical distributions of backscattered signals echoed by tissue compositions in the body. The backscattered signals are subject to the RF or Envelope data made available by an FDA-cleared general-purpose ultrasound system. The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.

Source page: https://510kreport.com/device/K162574
Methodology: https://510kreport.com/methodology