510(k) K260523 ยท QIH Automated Radiological Image Processing Software
QGuideCT (1.0)
| Applicant | Medis Medical Imaging Systems BV, Leiden, NL |
| Decision | Substantially Equivalent, Oct 5, 2026 |
| Received | Feb 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260523
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.