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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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Blood Bank Computer System
2.0.0
In Commercial Distribution

  • 00860009119406 ()


  • Blood bank information system application software
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
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
Picis Perioperative and Critical Care: An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10
In Commercial Distribution

  • 00851831007078 ()


  • Patient health record information system application software
An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
10C
In Commercial Distribution

  • 00851831007054 ()


  • Patient health record information system application software
An EMR system used in high acuity areas of the hospital (OR, ICU, Preop, PACU). A patient record is populated with information such as healthcare professionals, medical devices, and HIS/lab systems.
Picis Clinical Solutions, Inc.
8.6
In Commercial Distribution

  • 00851831007009 ()


  • Patient health record information system 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
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
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
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