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The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of the blood banking process.
ARC-ONE SOLUTIONS, LLC
1.0.33.0
Not in Commercial Distribution
- 00860003545409 ()
1.0.33.0
- Blood bank information system application software
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
cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist.
Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care.
cmTriage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist’s worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis.
cmTriage is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution
- 00860006442668 ()
- Radiology DICOM image processing application software
The CogNet AI-MT is a standalone software medical device for screening FFDM mammograms. This software is a triage device that allows the result to be prioritized for viewing by a qualified radiologist.
Medcognetics Inc
MT
In Commercial Distribution
- 00860007434709 ()
- X-ray image interpretive software
ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
Csl Plasma Inc.
1.0
In Commercial Distribution
- 00860007397615 ()
- Blood bank information system application software
LOGIC 4.0 is a web-based software application used to support daily operations of product logistics, primarily organizing and controlling the movement of plasma units between facilities such as warehouses and fractionators. The application also communicates observations or post donation information, status and recalls between collection, warehouse and fractionation facilities. LOGIC provides interface capabilities with sub-systems.
Csl Plasma Inc.
4.0
In Commercial Distribution
- 00860007397608 ()
- Blood bank information system application software
e-Delphyn LIS 21.x.x (US)
Gpi Usa, Inc.
21.x.x (US)
In Commercial Distribution
- 00860007282744 ()
- Blood bank information system
Surround 5.x
Gpi Usa, Inc.
5.x
- Blood bank information system
Donor Doc 3.x.x
Gpi Usa, Inc.
3.x.x
- Configurable electronic form web-based application software
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
- Blood bank information system