510(k) K210458 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
| Applicant | ABBOTT MEDICAL, Westford MA, US |
| Decision | Substantially Equivalent, Jun 8, 2021 |
| Received | Feb 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210458
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.