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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
In Commercial Distribution



  • Blood bank information system
ElDorado Donor 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Blood bank information system
e-Delphyn Donor version 11.x.x (US)
Gpi Usa, Inc.
11(US)
In Commercial Distribution

  • 00860007282706 ()


  • Blood bank information system
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
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
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
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
Donor Doc 3.x.x
Gpi Usa, Inc.
3.x.x
In Commercial Distribution



  • Configurable electronic form web-based application software
Regulated Software Application (RSA), Version 2.0 is a stand-alone blood establishment computer software application (BECS) that provides management controls and information services that have been designed to assist personnel in the operation of a blood center.
ARC-ONE SOLUTIONS, LLC
2.0.0.0
In Commercial Distribution

  • 00860006793708 ()
2.0.0.0

  • Blood bank information system application software
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