SoftTech AI Registry
GE HealthCare · Critical Care Suite

AI Pneumothorax Detection and Radiology Worklist Triage

On-device AI identifies findings consistent with pneumothorax in chest X-rays and generates a DICOM result for radiology workflows. The flag can be displayed and used to prioritise review where PACS/RIS supports and is configured for the integration. Clinical interpretation remains with qualified clinicians.

Recorded characteristics

Function
On-device AI identifies findings consistent with pneumothorax in chest X-rays and generates a result for radiology workflows, supporting notification for clinical review. Product versions are distinguished: the original Critical Care Suite pneumothorax function (FDA 510(k) K183182, 2019) and the later updated pneumothorax algorithm associated with Critical Care Suite 2.1 (FDA 510(k) K223491, 2023).
Data access
Chest X-ray images acquired on the supported GE HealthCare imaging system, processed on-device.
Actions
Can take actions
External actions
Yes
Human confirmation
Not required
Permission basis
Not established
Administrative control
Not established
Default state
Not established
Availability
Commercial Critical Care Suite functionality. Availability is qualified by product version (2.0 versus 2.1), equipment and jurisdiction. K183182 (2019) is not a blanket clearance for later algorithms; K223491 (2023) is distinct from the original clearance. The press release describing the later algorithm does not establish universal availability or deployment.
Licensing
Not established
External model or provider
Not established
Limitations and uncertainty
Action capability is limited to automatic flag generation and transmission. External action occurs via configured DICOM integration (DICOM public tags, C-STORE and MPPS) to compatible PACS/RIS worklists; display and prioritisation depend on local integration and configuration, and universal automatic queue reordering is not established. Human confirmation is not required for automated flagging; qualified physicians retain clinical interpretation responsibility. No independent clinical diagnosis or treatment decision is claimed. FDA clearances K183182 and K223491 apply to different algorithm generations and are not conflated. Permission basis and default state are not publicly established. Evidence recorded from Central Command controlled paraphrased claims; source pages not retrieved in this build; verification dates not established. No monitor: GE monitoring untested.

Evidence