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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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No Description
ELEKTA, INC.
XiO
Not in Commercial Distribution

  • 00858164002114 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Monaco
Not in Commercial Distribution

  • 00858164002046 ()


  • Radiation therapy software
No Description
ELEKTA, INC.
Atlas-Based Autosegmentation
Not in Commercial Distribution

  • 00858164002039 ()


  • Radiation therapy software
The HeartFlow Analysis is AI-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Heartflow, Inc.
FFRct version 3
In Commercial Distribution

  • 00853341006060 ()


  • Vascular modelling software
No Description
Cerner Corporation
CareAwareEventManagement6
In Commercial Distribution

  • 00853023006135 ()


  • Alarm application software
No Description
Cerner Corporation
CareAwareEventManagement5
In Commercial Distribution

  • 00853023006111 ()


  • Alarm application software
No Description
VARIAN MEDICAL SYSTEMS, INC.
5.0
In Commercial Distribution

  • 00850800006074 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
10.0
In Commercial Distribution

  • 00850800006067 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
4.1
In Commercial Distribution

  • 00850800006050 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00850800006043 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00850800006012 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
9.0
In Commercial Distribution

  • 00850800006005 ()


  • Radiation therapy software
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
HYLAND LLC
5.2.X
In Commercial Distribution

  • 00850677007419 ()
CS.5.2

  • Radiological PACS software
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear
HYLAND LLC
5.1.X
In Commercial Distribution



  • Radiological PACS software
Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007389 ()


  • Radiological PACS software
No Description
HYLAND LLC
3X
In Commercial Distribution

  • 00850677007341 ()
  • 00850677007358 ()


  • Radiological PACS software
No Description
HYLAND LLC
3X
In Commercial Distribution

  • 00850677007334 ()
  • 00850677007327 ()
  • 00850677007051 ()


  • Radiological PACS software
No Description
HYLAND LLC
2.X
Not in Commercial Distribution

  • 00850677007310 ()


  • Radiological PACS software
Encounter Manager
HYLAND LLC
2.X
Not in Commercial Distribution

  • 00850677007303 ()


  • Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007297 ()


  • Radiological PACS software
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