510(k) K253459— OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

Substantially Equivalent

ABBOTT MEDICAL

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2025-10-07
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westford, MA, US

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