# K250151: Us2.ca

- Pathway: 510(k) (Traditional)
- Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Decided: Jun 20, 2025 after 150 days
- Product code: SDJ (Adjunctive Cardiac Amyloidosis Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962603 (1997). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240860: EchoGo Amyloidosis (1.0), Ultromics Limited (2024) Summary page 5.

## Indications for use
Us2.ca processes acquired transthoracic cardiac ultrasound images to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in their diagnosis of cardiac amyloidosis. Us2.ca is intended for use only in adult patients with increased left ventricular wall thickness, defined as an interventricular septal thickness (IVSd) or left ventricular posterior wall thickness (LVPWd) > 12mm. Us2.ca is not intended to provide a diagnosis and does not replace current standards of care. The results from Us2.ca are not intended to exclude the need for further follow-up on cardiac amyloidosis.

Source page: https://510kreport.com/device/K250151
Methodology: https://510kreport.com/methodology