510(k) K253459
K253459 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2026
- Date Received
- October 7, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Optical Coherence Tomography (Oct)
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- SU
- Submission Type
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.