510(k) K261725 ยท SHL Ear, Nose, And Throat Image Analyzer
OtoCompanion (Version 1.0)
| Applicant | Ironsides Medical, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Sep 21, 2026 |
| Received | May 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261725
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.