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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
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution
- 00882916000530 ()
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution
- 00882916000516 ()
v1.x and v2.0
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
6.x
In Commercial Distribution
- 00882916000028 ()
- MRI system application software
- CT system application software
No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution
- 00882916000011 ()
- MRI system application software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.1.x
Not in Commercial Distribution
- 05902729753500 ()
- CAD/CAM software
Ortho System is a software system intended for use as a medical front-end for orthodontic clinics and laboratories. It supports orthodontic diagnosis, treatment planning and follow-up, CAD modelling of orthodontic appliances and indirect bonding as well as archiving of case information.
3shape A/S
85.x
In Commercial Distribution
- 05902729753487 ()
- Dental treatment application software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.2.x
In Commercial Distribution
- 05902729753630 ()
- CAD/CAM software
Dental treatment application software
3shape A/S
1.1.x
Not in Commercial Distribution
- 05902729752954 ()
- Dental treatment application software
cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.
cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).
cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070845012 ()
- Radiology DICOM image processing application software