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CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiographies. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiographies for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiographies for Aortic Dissection (AD). CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD on a standalone Web application in parallel to the ongoing standard of care image interpretation.
The user is presented with notifications for cases with suspected PE or AD findings. 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 CHEST 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
- B826CINACHEST100 ()
- Radiology DICOM image processing application software
CINA is a radiological computer-assisted triage and notification software device.
The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications.
DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application.
The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active
notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINA100 ()
- Radiology DICOM image processing application software
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
NICo-Lab B.V.
3
In Commercial Distribution
- 08720299502338 ()
- X-ray image interpretive software
No Description
Medit Corp.
2.0
In Commercial Distribution
- 08800026700869 ()
- CAD/CAM software
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution
- 03665324000050 ()
- Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution
- 03665324000036 ()
- Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution
- 03665324000005 ()
- Blood bank information system
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features:
• Bidirectional connectivity with one or more LIS.
• Provides the ability to centralize the management of Quality Control.
• Allows user to view and validate results remotely prior to export to LIS.
• Allows to create and print reports.
Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
In Commercial Distribution
- 08436583731215 ()
210404
- Blood bank information system application software
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and
managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
Not in Commercial Distribution
- 08436583730980 ()
210404
- Blood bank information system 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