# K181574: Uscan

- Pathway: 510(k) (Traditional)
- Applicant: EchoNous, Inc.
- Decided: Jul 10, 2018 after 25 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 179 ancestors in all.
No later device cites it as a predicate yet.
6 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160420: SpeqT, Signostics Limited (2016) Summary page 4.

## Indications for use
The Uscan is for non-invasive imaging of the human body and is intended for the following applications: Abdominal, Musculoskeletal, Pediatric, Small Organ, and Peripheral Vessel. Users must have ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. The Uscan can also be used to obtain an image of the bladder that is used to automatically determine bladder volume.

Source page: https://510kreport.com/device/K181574
Methodology: https://510kreport.com/methodology