510(k) K243863 · QIH Automated Radiological Image Processing Software
Opulus Lymphoma Precision
| Applicant | Roche Molecular Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, May 30, 2025 |
| Received | Dec 17, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243863
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.