FUJIFILM Healthcare Corporation 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 K241429

ECHELON Synergy MRI System

FUJIFILM Healthcare Corporation

Authorized purpose: The ECHELON Synergy MRI System provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, and extremities for trained physician interpretation.

Modality: MRI
Anatomy: Head, body, and extremities
Decision: 2024-08-13

MRI workflow

FDA-cleared K223426

ECHELON Synergy MRI system

FUJIFILM Healthcare Corporation

Authorized purpose: The ECHELON Synergy MRI system is a 1.5T MR imaging device that provides non-ionizing physiological and clinical information and produces transverse, coronal, sagittal, oblique, and curved cross-sectional images of the head, body, or extremities for trained-physician interpretation.

Modality: MRI
Anatomy: Head, spine, cardiac, breast, abdomen, pelvis, shoulder, wrist, knee, ankle, and other labeled whole-body regions
Decision: 2023-07-13

Breast imaging Cardiac imaging MSK and bone