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ClearRead Xray Server Pneumothorax
Riverain Technologies, Inc.
2.0.0
In Commercial Distribution
- M722X25064P250640 ()
- Radiological PACS software
ClearRead Xray Pneumothorax on Xray Platform
Riverain Technologies, Inc.
1.1.1
In Commercial Distribution
- M722X22145P212210 ()
- Radiological PACS software
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images.
StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.
Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
- CT system application software
No Description
BRAINOMIX LIMITED
11.2
In Commercial Distribution
- B720BX360TRIAGESTRO1120 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution
- B720BX360TRIAGELVO1110 ()
- X-ray image interpretive software
No Description
BRAINOMIX LIMITED
11.1
In Commercial Distribution
- B720BX360TRIAGEICH1110 ()
- X-ray image interpretive software
CTB software versions 2.3+
Annalise Critical Care AI is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies.
ANNALISE-AI PTY LTD
2.3+
In Commercial Distribution
- G140ANNALISECONTAINER70 ()
Annalisecontainer7
- Radiology DICOM image processing application software
StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution
- B926SSSX10 ()
- CT system application software
CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen.
The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings.
CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device.
This document is the property of Avicenna.AI and cannot be reproduced without written authorisation.
The results of CINA-VCF are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINAVCF100 ()
- Radiology DICOM image processing application software
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with
detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA-iPE are intended to be used in conjunction with other patient information and based on professional judgment to assist with the triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINAIPE100 ()
- Radiology DICOM image processing application software