Automated Aortic Stenosis Software (AutoAS)— 510(k) K254161
Substantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA 510(k) clearance K254161 for Automated Aortic Stenosis Software (AutoAS), Substantially Equivalent on 2026-03-27. Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Device class: 2.
Summary
GE Medical Systems Ultrasound & Primary Care Diagnostics' Automated Aortic Stenosis Software (AutoAS) is filed under POK, computer-assisted diagnostic software for lesions suspicious for cancer. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2060. It was a Traditional 510(k), and Radiology is both the classification panel and the review panel.
GE Medical Systems Ultrasound & Primary Care Diagnostics filed from Waukesha, Wisconsin. The decision came 95 calendar days after FDA received it (December 22, 2025 to March 27, 2026).
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Product code
- Product code POK
- Device class
- Class 2
- Regulation
- 21 CFR 892.2060
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code POK
view allMore clearances from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.