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FDA 510(k)

Automated Aortic Stenosis Software (AutoAS)

K-Number: K254161 · 2026-03-27

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Decision Date2026-03-27
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Automated Aortic Stenosis Software (AutoAS) is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2026-03-27 under approval number K254161. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Automated Aortic Stenosis Software (AutoAS)?

Automated Aortic Stenosis Software (AutoAS) is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K254161.

When was Automated Aortic Stenosis Software (AutoAS) approved by the FDA?

Automated Aortic Stenosis Software (AutoAS) received FDA 510(k) clearance on 2026-03-27, under approval number K254161.

What company makes Automated Aortic Stenosis Software (AutoAS)?

Automated Aortic Stenosis Software (AutoAS) is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.

What is the FDA product code for Automated Aortic Stenosis Software (AutoAS)?

The FDA product code for Automated Aortic Stenosis Software (AutoAS) is POK.

Related Clinical Trials

NCT07614100 Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves NOT_YET_RECRUITING NCT07596394 A Registry to Assess the Efficacy and Safety of Transcatheter Treatment for Aortic Valve Disease at the IRCCS Policlinico San Matteo Foundation in Pavia (Italy). RECRUITING NCT05261204 Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement ENROLLING_BY_INVITATION NCT05172960 ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve ACTIVE_NOT_RECRUITING NCT03112980 Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality ACTIVE_NOT_RECRUITING NCT06861361 Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients RECRUITING

Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40278172 A Narrative Review of the Evidence for Transcatheter Aortic Valve Implants. Journal of cardiovascular development and disease (2025)

Other Devices by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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