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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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Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.
Fujifilm Healthcare Americas Corporation
Synapse Cardiology PACS Software License
In Commercial Distribution

  • 00854904006015 ()


  • Radiology picture archiving and communication system workstation
Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts of image information that are handled by their offices each day.
Fujifilm Healthcare Americas Corporation
Synapse Radiology PACS Software License
In Commercial Distribution

  • 00854904006008 ()


  • Radiology picture archiving and communication system workstation
No Description
Voximetry, Inc.
V1.2
In Commercial Distribution

  • 00860010685402 ()


  • Nuclear medicine system workstation
The device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Radiopharmaceutical Imaging and Dosimetry, LLC
3DRD-001
In Commercial Distribution

  • 00860009926905 ()


  • Nuclear medicine system workstation
Hybrid Viewer is a software application for nuclear medicine and radiology. Based on user input, Hybrid Viewer processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. Hybrid Viewer is equipped with dedicated workflows which have predefined settings and layouts optimized for specific nuclear medicine investigations. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Hybrid Viewer is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.
Hermes Medical Solutions AB
7.0
In Commercial Distribution

  • 00859873006189 ()
P31

  • Nuclear medicine system workstation
Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Affinity is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.
Hermes Medical Solutions AB
4.0
In Commercial Distribution

P60

  • Nuclear medicine system workstation
AFFINITY is a software application used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.
Hermes Medical Solutions AB
3
Not in Commercial Distribution

P60

  • Nuclear medicine system workstation
Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Hermes Medical Solutions AB
6
In Commercial Distribution

  • 00859873006158 ()
P0

  • Nuclear medicine system workstation
AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.
Hermes Medical Solutions AB
2.0
Not in Commercial Distribution



  • Nuclear medicine system workstation
AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.
Hermes Medical Solutions AB
1.0
Not in Commercial Distribution

  • 00859873006134 ()


  • Nuclear medicine system workstation
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