Last updated: Nov. 29, 2021
|Critical Care Suite
|Endotracheal tube tip to carina measurement, detection and flagging of pneumothorax and insufficient image quality, flagging of quality checks on acquired image: Intelligent Protocol Check, Intelligent Auto Rotate, Intelligent Field of View
|Adult-size patients. Suspected of pneumothorax or intubated.
|Frontal Chest X-rays, PA/AP, 2D, acquired on mobile or fixed X-ray systems
|On-device notifications, automated measurements, worklist prioritization, auto-rotated image, AI prediction score, image overlay
|DICOM, secondary capture DICOM, public DICOM tags
|Embedded on-device and only available on GE systems
|Locally on dedicated hardware: embedded in X-ray device (available as an add-on software on GE’s AMX 240 and AMX Navigate mobile X-ray system). The Pneumothorax detection and automated quality checks are also available on Definium Tempo, Definium 646 HD and Definium 656 HD fixed X-ray systems.
|Trigger for analysis
|Automatically, right after the image acquisition
|< 3 sec
Certified, Class IIa , MDD
|510(k) cleared, Class II
|Intended use statements
|Intended use (according to CE)
|Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital X-ray system for the presence of critical findings (pneumothorax), quality checks and/or measurements (endotracheal tube positioning). Critical Care Suite is indicated for adult-size patients.
Indications for Use (full description):
Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital X-ray system for the presence of critical findings, quality checks and/or measurements.
When Critical Care Suite includes the Pneumothorax algorithm, it produces an onscreen notification, image overlay, and an image flag to enable case prioritization and diagnosis of critical findings (pneumothorax). This information is also transmitted to the radiologist for review.
When Critical Care Suite includes the Endotracheal Tube algorithm, it produces an on screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review.
Intended users include the clinical care team and radiologist.
Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray image by a qualified physician.
Critical Care Suite is indicated for adult-size patients.
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