# K251293: CardioVision

- Pathway: 510(k) (Traditional)
- Applicant: Icardio.Ai
- Decided: Nov 21, 2025 after 210 days
- Product code: QUO (Adjunctive Heart Failure Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222463: EchoGo Heart Failure, Ultromics Limited (2022) Summary page 5.

## Indications for use
The iCardio.ai CardioVision™ AI is an automated machine learning–based decision support system, indicated as a diagnostic aid for patients undergoing an echocardiographic exam consisting of a single PLAX view in an outpatient environment, such as a primary care setting. When utilized by an interpreting clinician, this device provides information that may be useful in detecting moderate or severe aortic stenosis. iCardio.ai CardioVision™ AI is indicated in adult populations over 21 years of age. Patient management decisions should not be made solely on the results of the iCardio.ai CardioVision™ AI analysis. iCardio.ai CardioVision™ AI analyzes a single cine-loop DICOM of the parasternal long axis (PLAX).

Source page: https://510kreport.com/device/K251293
Methodology: https://510kreport.com/methodology