# K254161: Automated Aortic Stenosis Software (AutoAS)

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Decided: Mar 27, 2026 after 95 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
AutoAS is a software application intended to assist medical professionals in the assessment of moderate/severe aortic stenosis (AS). The software uses an artificial intelligence (AI) algorithm to process previously acquired two-dimensional transthoracic echocardiography (2D-TTE) images to provide a suggestion of moderate/severe aortic stenosis along with an associated confidence metric that can be a diagnostic aid to a physician in a point of care or similar setting in determining if further evaluation is needed, including whether a full echocardiogram (2D, Doppler) needs to be performed. The results of AutoAS are not intended to be used on a stand-alone basis for clinical decision making and are not intended to supplement or replace a full echocardiographic examination. AutoAS results, along with the obtained ultrasound images, must be reviewed by a qualified physician. The AutoAS product is not intended to be used on patients who have prosthetic valves and/or have had prior valve repair or replacement. AutoAS software is indicated for use in adult patients and is intended to be an accessory to compatible ultrasound systems in environments where healthcare is provided.

Source page: https://510kreport.com/device/K254161
Methodology: https://510kreport.com/methodology