GE Healthcare (GE Medical Systems, LLC) radiology AI products

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Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

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 K213668

SIGNA Hero

GE Healthcare (GE Medical Systems, LLC)

Authorized purpose: SIGNA Hero is a 3.0T whole-body MR system for qualified technologists and interpreting physicians to acquire, reconstruct, display, and export labeled diagnostic MR examinations using supported coils, sequences, and applications.

Modality: MRI
Anatomy: Multi-region
Decision: 2022-01-20

MRI workflow

FDA-cleared K193282

SIGNA Premier

GE Healthcare (GE Medical Systems, LLC)

Authorized purpose: SIGNA Premier is a 3.0T, 70 cm bore whole-body MRI system for diagnostic imaging across multiple anatomies; K193282 adds AIR Recon DL, a deep-learning reconstruction option intended to improve signal-to-noise ratio and image sharpness and enable shorter acquisitions while preserving those properties, with images and spectra interpreted by a trained physician.

Modality: MRI
Anatomy: Multi-region
Decision: 2020-04-10

MRI workflow