ABBOTT MEDICAL radiology AI products

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Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

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FDA-cleared K253459

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

ABBOTT MEDICAL

Authorized purpose: Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment of coronary vessels.

Modality: Optical Coherence Tomography
Anatomy: Coronary arteries
Decision: 2026-04-24

Cardiac imaging Quantification and segmentation

FDA-cleared K210458

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Abbott Medical

Authorized purpose: OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System acquire, display, and analyze intravascular optical coherence tomography images for trained professionals in the labeled coronary and interventional workflow.

Modality: Optical Coherence Tomography
Anatomy: Coronary arteries and intravascular anatomy
Decision: 2021-06-08

Cardiac imaging