FDA-Cleared AI Device

TrueFidelity CT

GE HealthCare

A deep learning image reconstruction engine for CT, aimed at preserving image texture at reduced radiation dose compared with iterative reconstruction.

At A Glance

Manufacturer
GE HealthCare
Medical specialty
Radiology
Clearance route
510(k)
Year authorized
2019
Modality
CT
Role in workflow
Image reconstruction

The stated goal is dose, and the specific complaint being answered is that iterative reconstruction produces images radiologists describe as plastic or waxy. Restoring conventional texture at lower dose is as much a readability argument as a physics one.

Where It Is Used

  • Dose reduction protocols
  • Low-contrast detectability in abdominal imaging
  • Pediatric imaging where dose is constrained

Limitations Worth Knowing

Dose reduction claims are protocol-specific and not transferable across body regions or patient sizes. Quantitative measurements made on deep learning reconstructions may not be interchangeable with those from filtered back projection, which matters for longitudinal comparison.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.

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