X-ray image interpretive software

Intended purpose

This device is intended as a computer aided triage and diagnosis device that analyzes frontal chest x-ray images acquired on a digital x-ray system for the presence of prespecified critical findings (e.g. pneumothorax). The device produces an on-screen notification and an image flag to enable case prioritization. Critical Care Suite provides adjunct information to aid with the prioritization and diagnosis of critical findings. Intended users includes technologist, clinical care team, and radiologist.It is intended for notification only and does not provide diagnostic information beyond the notification. This device should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. This device is not intended to replace the review of the x-ray image by a qualified physician. This device is indicated for adult-size patients.