Clearance Summary
Automated Aortic Stenosis Software (AutoAS) received FDA 510(k) clearance under submission number K254161, sponsored by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-03-27.
- Submission: K254161
- Applicant / Sponsor: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2060
- Decision date: 2026-03-27
Classification & Regulation
This clearance is catalogued under FDA product code POK and 21 CFR 892.2060, within the Radiology review panel as a Class II device.