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No Description
Blood Bank Computer System
2.0.0
In Commercial Distribution
- 00860009119406 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.0
Not in Commercial Distribution
- 00860271000907 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.4.0
In Commercial Distribution
- 00860271000952 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.4
Not in Commercial Distribution
- 00860271000945 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.3
Not in Commercial Distribution
- 00860271000938 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.2
Not in Commercial Distribution
- 00860271000921 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.3.1
Not in Commercial Distribution
- 00860271000914 ()
- Blood bank information system application software
Lattice MediCopia for Specimen Collection, Transfusion Administration, Breast Milk and Anatomic Pathology.
Lattice Incorporated
4.x.x
In Commercial Distribution
- 00860014128905 ()
- Blood bank information system application software
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
7
In Commercial Distribution
- 00860002380087 ()
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
6.0
In Commercial Distribution
- 00860002380070 ()
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
5.9
Not in Commercial Distribution
- 00860002380049 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
Version 5.8
In Commercial Distribution
- 00860002380032 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
Version 5.6
In Commercial Distribution
- 00860002380025 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
Ulab Systems, Inc.
Version 5.5
Not in Commercial Distribution
- 00860002380018 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
Ulab Systems, Inc.
Version 5
Not in Commercial Distribution
- 00860002380001 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
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
V2.3 and subsequent minor V2.x releases
In Commercial Distribution
- 00860001219531 ()
- Radiology DICOM image processing application software
Saige-Q is a software workflow device that processes Digital Breast Tomosynthesis (DBT) and Full-Field Digital Mammography (FFDM) screening mammograms using artificial intelligence to act as a prioritization tool for interpreting radiologists. By automatically indicating whether a given mammogram is suspicious for malignancy, Saige-Q can help the user prioritize or triage cases in their worklist (or queue) that may benefit from prioritized review.
Saige-Q takes as input a set of x-ray mammogram DICOM files from a single screening mammography study (FFDM or DBT). The software first checks that the study is appropriate for Saige-Q analysis and then extracts, processes and analyses the DICOM images using an artificial intelligence algorithm. As a result of the analysis, the software generates a Saige-Q code indicating the software’s suspicion of the presence of findings suggestive of breast cancer. For mammograms given a Saige-Q code of “Suspicious,” the software also generates a compressed preview image, which is for informational purposes only and is not intended for diagnostic use.
The Saige-Q code can be viewed by radiologists on a picture archiving and communication system (PACS), Electronic Patient Record (EPR), and/or Radiology Information System (RIS) worklist and can be used to reorder the worklist. As a software-only device, Saige-Q can be hosted on a compatible host server connected to the necessary clinical IT systems such that DICOM studies can be received and the resulting outputs returned where they can be incorporated into the radiology worklist.
The Saige-Q codes can be used for triage or prioritization. For example, “Suspicious” studies could be given prioritized review. With a worklist that supports sorting, batches of mammograms could also be sorted based on the Saige-Q code.
Deephealth, Inc.
2.2.0
In Commercial Distribution
- 00860005144006 ()
- Radiology DICOM image processing application software
Qure.ai Head CT scan interpretation software, qER, is a deep-learning-based software device that analyses head CT scans for signs of intracranial hemorrhage, midline shift, mass effect or cranial fractures in order to prioritize them for clinical review. The standalone software device consists of an on-premise module and a cloud module. qER accepts non-contrast adult head CT scan DICOM files as input and provides a priority flag indicating critical scans.
QURE.AI TECHNOLOGIES PRIVATE LIMITED
2.0.0
In Commercial Distribution
- 00860005118106 ()
- Radiology DICOM image processing application software
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