OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

ABBOTT MEDICAL · K253459 · 2026-04-24

OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) is an AI-enabled medical device from ABBOTT MEDICAL, listed by FDA (510(k), K253459) with a decision date of 2026-04-24. Review panel: Radiology.

FDA submission numberK253459
Pathway510(k)
CompanyABBOTT MEDICAL
Review panel (specialty)Radiology
FDA decision date2026-04-24
DecisionSubstantially Equivalent
Product codeNQQ
ClassificationSystem, Imaging, Optical Coherence Tomography (Oct)
Device class2
Regulation number892.1560
Review time (calendar days)199
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.