Search Results

EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computer-aided triage and notification software indicated for use in the analysis of chest X-ray (CXR) images in adults. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina. Findings are flagged when the ETT distal tip is assessed as being more than 7 cm above the carina, less than 3 cm above the carina, or when it is below the carina (i.e in the right or left mainstem bronchus). The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device is tested in the single lumen endotracheal tube, while it may trigger a false prioritization alert in the case of properly positioned double lumen ETT. EFAI ETTXR analyzes cases using algorithms to identify suspected malpositioned ETT findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI ETTXR is not intended to direct attention to specific portions of an image or to anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out malpositioned ETT or otherwise preclude clinical assessment of chest radiographs.

EFAI CHESTSUITE XR MALPOSITIONED ETT ASSESSMENT SYSTEM (EFAI ETTXR) is a radiological computer-assisted triage and notification software system. The software uses deep learning techniques to automatically analyze chest radiographs and alerts the PACS/RIS workstation once images with features suggestive of malpositioned ETT are identified. Through the use of EFAI ETTXR, a radiologist is able to review studies with features suggestive of malpositioned ETT earlier than in standard of care workflow. The device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It does not mark, highlight, or direct users' attention to a specific location on the original chest radiographs. The device aims to aid in prioritization and triage of radiological medical images only.

EFAI NEUROSUITE CT MIDLINE SHIFT ASSESSMENT SYSTEM (EFAI MLSCT) is a software workflow tool designed to aid in prioritizing the clinical assessment of non-contrast head CT cases with features suggestive of midline shift (MLS) in individuals aged 18 years and above. EFAI MLSCT analyzes cases using deep learning algorithms to identify suspected MLS findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI MLSCT is not intended to direct attention to specific portions of an image or to anomalies other than MLS. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out MLS or otherwise preclude clinical assessment of CT studies.

EFAI NEUROSUITE CT MIDLINE SHIFT ASSESSMENT SYSTEM (EFAI MLSCT) is a radiological computer-assisted triage and notification software system. The software uses deep learning techniques to automatically analyze non-contrast head CTs and alerts the PACS/RIS workstation once images with features suggestive of MLS are identified. Through the use of EFAI MLSCT, a radiologist is able to review studies with features suggestive of MLS earlier than in standard of care workflow. The device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It does not mark, highlight, or direct users' attention to a specific location on the original non-contrast head CT. The device aims to aid in prioritization and triage of radiological medical images only.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer aided triage and notification software indicated for use in the analysis of chest-abdomen CTA in adults aged 22 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology. EFAI AASCTA uses an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI AASCTA is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decisionmaking nor is it intended to rule out AAS or otherwise preclude clinical assessment of computed tomography cases.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer-assisted triage and notification software system. The software uses deep learning techniques to automatically analyze chest or chest-abdomen CTA and alerts the PACS/RIS workstation once images with features suggestive of AD or IMH are identified. Through the use of EFAI AASCTA, a radiologist is able to review studies with features suggestive of AD or IMH earlier than in standard of care workflow. The device is intended to provide a passive notification through the PACS/workstation to the radiologists indicating the existence of a case that may potentially benefit from the prioritization. It does not mark, highlight, or direct users' attention to a specific location on the original chest or chest-abdomen CTA. The device aims to aid in prioritization and triage of radiological medical images only.