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.
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Product code
- 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
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