FDA 510(k) clearance · back to tracker

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

ABBOTT MEDICAL cleared K253459 on 2026-04-24, decision: substantially equivalent

K-number

K253459

Sponsor

ABBOTT MEDICAL

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-04-24

Product code

NQQ

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1560

Official FDA record

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FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.