SDJ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Adjunctive Cardiac Amyloidosis Status Indicator

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2200

Medical specialty

Cardiovascular

FDA 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.

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