# K240860: EchoGo Amyloidosis (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Ultromics Limited
- Decided: Nov 15, 2024 after 232 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: 14 generations back to K962603 (1997). 58 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222463: EchoGo Heart Failure, Ultromics Limited (2022) Summary page 5.

## Most influential descendants
- K250151: Us2.ca (2025), 0 descendants of its own
- K243866: InVision Precision Cardiac Amyloid (2025), 0 descendants of its own

## Indications for use
EchoGo Amyloidosis 1.0 is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over with heart failure undergoing cardiovascular assessment using echocardiography. When utilised by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. EchoGo Amyloidosis 1.0 is indicated in adult patients aged 65 years and over with heart failure. Patient management decisions should not be made solely on the results of the EchoGo Amyloidosis 1.0 analysis.

Source page: https://510kreport.com/device/K240860
Methodology: https://510kreport.com/methodology