K253459
- 510(k) number
- K253459
- Device name
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- Applicant
- ABBOTT MEDICAL MA · US
- Product code
- NQQ — System, Imaging, Optical Coherence Tomography (Oct)
- Decision date
- 2026-04-24
- Date received
- 2025-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253459.pdf
Official FDA record: K253459
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.