CardioVision

FDA 510(k) K251293 · Icardio.Ai

Substantially Equivalent

510(k) numberK251293

Submission

Device name
CardioVision
Applicant
Icardio.Ai
West Hollywood, CA, US
Received
April 25, 2025
Decision date
November 21, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QUO – Adjunctive Heart Failure Status Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2200
Specialty
Cardiovascular

The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. 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 QUO

510(k)DeviceApplicantDecision
K240013EchoGo Heart Failure (2.0)QUO · Traditional Ultromics Limited09/23/2024SE
K223905Vivio® LVEDP SystemQUO · Traditional Avicena, LLC10/06/2023SE
K222463EchoGo Heart FailureQUO · Traditional Ultromics Limited11/23/2022SE

More from Ultromics Limited

510(k)DeviceDecision
K241430EchoMeasureQIH · Traditional 10/10/2024SE

Questions and answers

When was CardioVision cleared by the FDA?

CardioVision (K251293) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 210 days after the submission was received.

What is the product code of K251293?

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