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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 the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2026-03-27 under 510(k) 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. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K254161.

When did Automated Aortic Stenosis Software (AutoAS) receive FDA 510(k) clearance?

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

Who is the listed applicant for Automated Aortic Stenosis Software (AutoAS)?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as applicant

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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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