# K241245: EchoSolv AS

- Pathway: 510(k) (Traditional)
- Applicant: Echo IQ, Ltd.
- Decided: Oct 4, 2024 after 154 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913770 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201555: EchoGo Pro, Ultromics, Ltd. (2020) Summary page 5.

## Indications for use
EchoSolv AS is a machine learning (ML) and artificial intelligence (AI) based decision support software indicated for use as an adjunct to echocardiography for assessment of severe aortic stenosis (AS). When utilized by an interpreting physician, this device provides information to facilitate rendering an accurate diagnosis of AS. Patient management decisions should not be made solely on the results of the EchoSolv AS analysis. EchoSolv AS includes both the algorithm based AS phenotype analysis, and the application of recognized AS clinical practice guidelines. Limitations: EchoSolv AS is not intended for patients under the age of 18 years or those who have previously undergone aortic valve replacement surgery

Source page: https://510kreport.com/device/K241245
Methodology: https://510kreport.com/methodology