EchoGo Amyloidosis (1.0)

FDA 510(k) K240860 · Ultromics Limited

Substantially Equivalent

510(k) numberK240860

Submission

Device name
EchoGo Amyloidosis (1.0)
Applicant
Ultromics Limited
Oxford, GB
Received
March 28, 2024
Decision date
November 15, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
SDJ – Adjunctive Cardiac Amyloidosis Status Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2200
Specialty
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.

Other 510(k)s with product code SDJ

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

More from InVision Medical Technology Corporation

510(k)DeviceDecision
K240013EchoGo Heart Failure (2.0)QUO · Traditional 09/23/2024SE
K222463EchoGo Heart FailureQUO · Traditional 11/23/2022SE
K213275EchoGo Core (2.0)QIH · Traditional 12/20/2021SE
K201555EchoGo ProPOK · Traditional 12/18/2020SE
K191171EchoGo CoreQIH · Traditional 11/13/2019SE

Questions and answers

When was EchoGo Amyloidosis (1.0) cleared by the FDA?

EchoGo Amyloidosis (1.0) (K240860) received a 510(k) decision of Substantially Equivalent on November 15, 2024, 232 days after the submission was received.

What is the product code of K240860?

The FDA product code is SDJ – Adjunctive Cardiac Amyloidosis Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.