FDA-Cleared AI Device

Aidoc BriefCase

Aidoc

A family of computer-aided triage modules that scan CT studies as they arrive and move suspected positives to the front of the radiologist worklist. Cleared across multiple findings including intracranial hemorrhage, pulmonary embolism, and cervical spine fracture.

At A Glance

Manufacturer
Aidoc
Medical specialty
Radiology
Clearance route
510(k)
Year authorized
2018 onward
Modality
CT
Role in workflow
Triage and notification

BriefCase is a triage device, not a diagnostic one. That distinction is written into the clearance: the software does not produce a diagnosis, does not mark the image for the reader, and does not remove a study from the queue. It changes the order in which studies are read.

The clinical argument is time. In stroke and hemorrhage, the interval between image acquisition and a clinician acting on it is the outcome variable that actually moves. A triage device that shortens that interval can improve care without ever being more accurate than the radiologist who eventually reads the study.

Where It Is Used

  • Intracranial hemorrhage triage on non-contrast head CT
  • Pulmonary embolism triage on CT angiography
  • Cervical spine fracture triage
  • Pneumothorax and incidental finding notification

Limitations Worth Knowing

Triage clearances are evaluated on sensitivity and time-to-notification, not on diagnostic accuracy. A high false-positive rate is tolerable within a triage indication and can still be disruptive in practice, because every false flag consumes attention. Performance is also worklist-dependent: in a low-volume department where studies are read promptly anyway, the time benefit that justifies the device largely disappears.

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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