Automated Aortic Stenosis Software (AutoAS)

510(k) Number

K254161 ↗

FDA Product Code

POK

FDA applicant

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Device Class

Class II

Regulation

21 CFR Part 892.2060

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Venue Focus

  Class IIa

  CE/MDR

• 6800000PRM

  Class IIa

  CE/MDR

• Vivid T8, Vivid T9

  Class II

  FDA 510(k) K200851 Active Cleared 9 Sep 2020

• Logiq P10, Logiq P9, Logiq P8

  Class II

  FDA 510(k) K203114 Active Cleared 8 Jan 2021

• Vivid E80, Vivid E90, Vivid E95

  Class II

  FDA 510(k) K170823 Active Cleared 12 Jun 2017

• Vivid T9/Vivid T8

  Class II

  FDA 510(k) K243628 Active Cleared 11 Feb 2025

See all devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC →

• What clinical setting is the Automated Aortic Stenosis Software (AutoAS) designed for, and how does it integrate with existing workflows?

  AutoAS is specifically designed for use in radiology settings where ultrasound imaging is performed. It integrates as a digital application with compatible ultrasound platforms, automating the assessment of aortic stenosis severity by providing quantitative measurements—such as valve area, mean gradient, and velocity-time integral—directly from ultrasound data. This streamlines workflows by reducing manual calculations and aiding clinicians in making faster, data-driven decisions during diagnostic evaluations.

• Is the Automated Aortic Stenosis Software (AutoAS) a single-use or reusable product, and what are the sterility requirements?

  AutoAS is a software-based tool and does not require sterility or single-use considerations. Since it operates as a digital application integrated into ultrasound systems, it is designed for repeated use across multiple patients without any limitations related to sterility or disposal. This aligns with its classification as a computer-assisted diagnostic tool rather than a physical medical device.

• How does the Automated Aortic Stenosis Software (AutoAS) differ from traditional manual methods for assessing aortic stenosis?

  AutoAS automates the assessment of aortic stenosis by processing ultrasound data to generate quantitative measurements—such as valve area, mean gradient, and velocity-time integral—without manual input. This reduces variability in measurements and accelerates diagnostic workflows compared to traditional manual calculations, which rely on clinician interpretation and can be time-consuming. The software provides standardized, reproducible results to support clinical decision-making.

• What regulatory pathways has the Automated Aortic Stenosis Software (AutoAS) followed, and what does this mean for its use in clinical practice?

  AutoAS has undergone FDA 510(k) clearance under the POK product code, demonstrating it is substantially equivalent to a predicate device. It also complies with EU MDR requirements, ensuring it meets regulatory standards for safety and performance in both U.S. and European markets. Clinicians can rely on its validated design and regulatory approvals when integrating it into diagnostic workflows for aortic stenosis assessment.