510(k) K261623 ยท QIH Automated Radiological Image Processing Software
EchoPAC Software Only / EchoPAC Plug-in (v211)
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 16, 2026 |
| Received | May 15, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261623
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.