510(k) K202300 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
| Applicant | Optellum, Ltd., Oxford, GB |
| Decision | Substantially Equivalent, Mar 5, 2021 |
| Received | Aug 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202300
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.