510(k) K242461 ยท QIH Automated Radiological Image Processing Software
IRISeg
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 10, 2024 |
| Received | Aug 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242461
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.