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AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage.
AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
MAXQ AI LTD
V1.6
In Commercial Distribution
- 00860001219500 ()
ACC-IX0 V1.6 and V2.2
- Radiology DICOM image processing application software
Feops HEARTguide Simulation Application
FEops
3.1.0
In Commercial Distribution
- 05430002070094 ()
05430002070094
- Radiology DICOM image processing application software
FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
The version v1.4.2 supports next to the WATCHMAN device also the WATCHMAN FLX and the AMULET devices
FEops
1.4.2
Not in Commercial Distribution
- 05430002070070 ()
- Radiology DICOM image processing application software
FEops HEARTguide Simulation Application
FEops
3.0.0
Not in Commercial Distribution
- 05430002070056 ()
05430002070056
- Radiology DICOM image processing application software
FEops HEARTguide™ is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient’s clinical history, symptoms, and other preprocedural evaluations, as well as the clinician’s professional judgment.
FEops HEARTguide™ is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ is prescription use only.
FEops
1.4.1
Not in Commercial Distribution
- 05430002070032 ()
- Radiology DICOM image processing application software
No Description
MEDHOST OF TENNESSEE, INC.
9.0
In Commercial Distribution
- 00869202000214 ()
- Blood bank information system application software
CorVista System with PH Add-On
Analytics for Life Inc.
CorVista System with PH Add-On
In Commercial Distribution
- 00869059000443 ()
- Multiparameter physiologic analysis workstation
NDDR and CDCS is a web-based application that is intended to meet the needs of participating donation centers to check for the presence of recent blood or blood components (including plasma) donations at other donation centers by a prospective donor, as well as check if prospective donors have been deferred by participating donation centers.
CIELOWORKS, INC.
2.3
In Commercial Distribution
- 00860011763208 ()
- Blood bank information system application software
Configurable Software for managing manually entered blood test results.
Rubin & Poor, Inc.
CTS 1.5A
In Commercial Distribution
- 00860010612866 ()
4
- Blood bank information system application software
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
QTX - V1.1a(WinSQL 1.0c)
In Commercial Distribution
- 00860010612859 ()
6
- Blood bank information system application software