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.
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
- 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
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