FDA-cleared K253459
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
ABBOTT MEDICAL
Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment...
- Modality
- Optical Coherence Tomography
- Anatomy
- Coronary arteries
- Decision
- 2026-04-24