OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)

ABBOTT MEDICAL

510k4/24/2026

FDA #

K253459

Product Code

NQQ

Panel

Cardiovascular

Modality:OCT Task:Image Synthesis Body Region:Cardiac

The OPTIS Mobile Next and Integrated Next Imaging Systems along with the Ultreon 3.0 Software Upgrade Kit are advanced OCT imaging systems designed for cardiovascular imaging. These devices assist clinicians by providing high-resolution images of blood vessels, aiding in diagnosis and treatment planning for cardiovascular conditions.

Predicate Devices

No predicate devices specified

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