FDA-Cleared AI Device

Critical Care Suite

GE HealthCare

An AI package embedded in the X-ray system itself rather than in the PACS. Analyzes chest radiographs on the device seconds after acquisition and flags suspected pneumothorax before the image reaches the reading queue.

At A Glance

Manufacturer
GE HealthCare
Medical specialty
Radiology
Clearance route
510(k)
Year authorized
2019
Modality
Chest X-ray
Role in workflow
Triage and notification

The interesting design decision here is location. Most imaging AI runs downstream in the PACS, which means the finding surfaces after the study has been transmitted, queued, and routed. Running the model on the X-ray unit itself collapses all of that, and in a portable ICU setting the technologist is still at the bedside when the flag appears.

Where It Is Used

  • Point-of-acquisition pneumothorax flagging
  • ICU and emergency portable radiography
  • Automatic endotracheal tube placement assessment in later versions

Limitations Worth Knowing

On-device inference constrains model size and update cadence: the algorithm ships with the equipment and does not improve between service updates. The indication is also narrow. This is not a general chest X-ray reader, and the flag applies to a single finding class.

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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