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NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution
- 15099590683276 ()
B91240
- Laboratory instrument/analyser application software IVD
Cytomics FC 500 MPL with MXP Software
Beckman Coulter, Inc.
UPS (MPL)
In Commercial Distribution
- 15099590572822 ()
626554
- Flow cytometry analyser IVD, semi-automated
ViroSeq HIV-1 Genotyping Software v3.0 & Algorithm Advisor
ABBOTT MOLECULAR INC.
4J94-23
In Commercial Distribution
- 00884999039278 ()
4J94-23
- Laboratory instrument/analyser application software IVD
Earlens Fitting Software. Lot Number is for manufacturing packaging of software. Version is in Application Identifier (8012).
EARLENS CORPORATION
ELF001
Not in Commercial Distribution
- 00850013007042 ()
ELF001
- Audiometric/hearing device software
Software, TomoApps, Version 5.1.3
Operating Software for TomoTherapy systems (including TomoH, TomoHD, TomoHDA) and Onrad Treatment System.
ACCURAY INCORPORATED
1062424
In Commercial Distribution
- M65810624240 ()
NA
- Linear accelerator system
VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
BIOMERIEUX , INC.
9.01.1
In Commercial Distribution
- 03573026619060 ()
- Microorganism identification/antimicrobial-susceptibility analyser IVD
BriefCase is a radiological computer aided triage and notification software device. Software version 3.0.0 for CSF triage
AIDOC MEDICAL LTD
3.0.0
Not in Commercial Distribution
- 07290018052037 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 2.0.0 for PE triage
AIDOC MEDICAL LTD
2.0.0
Not in Commercial Distribution
- 07290018052020 ()
- Radiology DICOM image processing application software
BriefCase is a radiological computer aided triage and notification software device. Software version 1.1.0.0 for ICH triage.
AIDOC MEDICAL LTD
1.1.0.0
Not in Commercial Distribution
- 07290018052013 ()
- Radiology DICOM image processing application 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