Adjunctive Cardiac Amyloidosis Status Indicator

FDA product code SDJ · Class II (moderate risk) · 21 CFR 870.2200 · Cardiovascular

The adjunctive cardiac amyloidosis status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting cardiac amyloidosis. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K250151Us2.caSDJ · Traditional Eko.Ai Pte Ltd. D/B/A Us2.Ai06/20/2025SE
K243866InVision Precision Cardiac AmyloidSDJ · Traditional InVision Medical Technology Corporation05/21/2025SE
K240860EchoGo Amyloidosis (1.0)SDJ · Traditional Ultromics Limited11/15/2024SE