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EchoSolv As

by Echo IQ, Ltd. 510(k)

Active United States

510(k) K241245

Overview

The EchoSolv As is a computer-assisted diagnostic software for lesions suspicious for cancer, classified under the medical specialty of Radiology. It is designed to assist in the diagnosis of severe aortic stenosis using artificial intelligence. The device is intended to help identify patients at risk of structural heart disease. It is an AI-enabled medical device that uses proprietary artificial intelligence to analyze echocardiograms. The device is used in the field of radiology.

The EchoSolv As is supplied as a software platform and is regulated under the product code POK. It has received FDA 510K authorization, with a clearance type of Traditional and a decision code of SESE. The device is associated with the regulation number 892.2060 and has been assigned the device class 2. It is available with the k number K241245 and fei numbers 3017604664, 3040335643, 3022983474, 3033588305, 3034527804, 3016585383, 3010119782, 3014269683, 3044622018, 3017210169, 3029937167, 3015478020, and 3007301305.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241245 Date4 Oct 2024ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
POK
Device Class
Class II
Regulation
21 CFR Part 892.2060
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Echo IQ, Ltd.

Questions

  • What is the EchoSolv AS used for?

    The EchoSolv AS is used to assist in the diagnosis of severe aortic stenosis and identify patients at risk of structural heart disease, using artificial intelligence to analyze echocardiograms.

  • How is the EchoSolv AS supplied?

    The EchoSolv AS is supplied as a software platform, classified under the product code POK.

  • Is the EchoSolv AS a single-use or reuse device?

    The EchoSolv AS is a software platform, so it is not a single-use or reuse device in the classical sense, but rather a tool used to analyze echocardiograms.

  • What regulatory authorizations has the EchoSolv AS received?

    The EchoSolv AS has received FDA 510K authorization, with a clearance type of Traditional and a decision code of SESE, and is regulated under the product code POK.