GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC radiology AI products

FDA-cleared K254161

Automated Aortic Stenosis Software (AutoAS)

GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Assist assessment of moderate/severe aortic stenosis and help determine whether further evaluation, including a full echocardiogram, is needed.

Modality: Ultrasound
Anatomy: Heart/cardiovascular system, specifically the aortic valve and aortic stenosis assessment
Decision: 2026-03-27

Cardiac imaging Ultrasound workflow

FDA-cleared K221148

Vivid iq

GE Medical Systems Ultrasound & Primary Care Diagnostics LLC

Vivid iq is compact cardiac and general ultrasound; this release adds thoracic and pleural applications, new transducers, and AI-assisted Easy Auto EF and Easy AFI LV functions.

Modality: Ultrasound
Anatomy: Heart/Cardiovascular
Decision: 2022-07-18

Cardiac imaging Ultrasound workflow