510(k) K254161 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Automated Aortic Stenosis Software (AutoAS)
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 27, 2026 |
| Received | Dec 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254161
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.