OMB Individually Reported

TeraRecon iNtuition-Structural Heart Module

High riskExact public inventory row

Description

The iNtuition-Structural Heart Module is an iNtuition (K121916) based optional feature that employs all standard features offered by iNtuition. These standard features include convenient image manipulation tools (like drawing of region of interests), manual and automatic segmentation of structures, image assessment and measurement tools (linear, diameter, perimeter, angle, area and volume) and tools that support report creation, transmission and storage of reports in digital form, and tracking of historical information about the studies analyzed by the software. iNtuition Vessel analysis and calcium scoring features are utilized to support automatic and manual centerline extraction and analysis and calcium quantification.

Detailed example

Image segmentations and measurements.

AI / analytics pattern

Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Accelerate standard cardiology workflows.

Controls / human review

ATO: Not reported; PIA: Not published