OPTIS Mobile Next Imaging System (1014932) +2 more— 510(k) K253459
Substantially EquivalentABBOTT MEDICAL
FDA 510(k) clearance K253459 for OPTIS Mobile Next Imaging System (1014932) +2 more, Substantially Equivalent on 2026-04-24. Applicant: ABBOTT MEDICAL. Device class: 2.
Summary
Abbott Medical's record names three items: the OPTIS Mobile Next Imaging System (1014932), the OPTIS Integrated Next Imaging System (1014933), and the Ultreon 3.0 Software Upgrade Kit (ULTR300001). All three are filed under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)).
Class II, 21 CFR 892.1560. The Cardiovascular review panel handled it as a Traditional 510(k), though the record lists Radiology as the classification panel.
Abbott Medical filed from Westford, Massachusetts. The record shows 199 calendar days from receipt to decision (October 7, 2025 to April 24, 2026).
Clearance details
- Device name as filed
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- Applicant
- ABBOTT MEDICAL
- Product code
- Product code NQQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westford, MA, US
Recent devices under product code NQQ
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