510(k) K251763 ยท QIH Automated Radiological Image Processing Software
IRISeg
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Jun 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251763
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.