510(k) K254161

Automated Aortic Stenosis Software (AutoAS) by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code POK

K254161 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "Automated Aortic Stenosis Software (AutoAS)". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2060. GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has at least 10 other 510(k) clearances on record.