SDJ

Adjunctive Cardiac Amyloidosis Status Indicator

Product code

SDJ

Device name

Adjunctive Cardiac Amyloidosis Status Indicator

Device class

Class 2

21 CFR

21 CFR 870.2200

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-06-20.

3 summaries are archived here for direct download.