510(k) K232386 · NQQ System, Imaging, Optical Coherence Tomography (Oct)
ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
| Applicant | ABBOTT MEDICAL, Westford MA, US |
| Decision | Substantially Equivalent, Sep 8, 2023 |
| Received | Aug 9, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232386
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.