FDA 510(k)

自動主動脈瓣膜狭窄軟件（AutoAS）

K 號：K254161 · 2026-03-27

申請人GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

決定日期2026-03-27

產品代碼POK

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.