K254161
- 510(k) number
- K254161
- Device name
- Automated Aortic Stenosis Software (AutoAS)
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC WI · US
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2026-03-27
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K254161.pdf
Official FDA record: K254161
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.