K254161 is an FDA 510(k) clearance for the Automated Aortic Stenosis Software (AutoAS). This device is classified as a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II - Special Controls, product code POK).
Submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Waukesha, US). The FDA issued a Cleared decision on March 27, 2026, 95 days after receiving the submission on December 22, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2060. Assist Users In Characterizing Lesions Identified On Acquired Medical Images.
| 510(k) Number | K254161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2025 |
| Decision Date | March 27, 2026 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | POK - Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2060 |
| Definition | Assist Users In Characterizing Lesions Identified On Acquired Medical Images |