DeviceClearance

Product code SDJ— Cardiovascular

EchoGo Amyloidosis (1.0)

Classification name
Adjunctive Cardiac Amyloidosis Status Indicator
Device class
Class 2
Regulation
21 CFR 870.2200
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SDJ under 21 CFR 870.2200, via openFDA

Market context for product code SDJ

FDA has cleared 3 devices under product code SDJ between 2024 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SDJ

Recent clearances under product code SDJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.