510(k) K253459 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
| Applicant | ABBOTT MEDICAL, Westford MA, US |
| Decision | Substantially Equivalent, Apr 24, 2026 |
| Received | Oct 7, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253459
No recall in the FDA data names this 510(k).
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