510(k) K260755 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
OptraSCAN System
| Applicant | Optrascan, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Mar 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260755
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.