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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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Synapse Mobility - 00854904006053

Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side rendering technology to stream imaging securely and fast to any authorized user, with the ability to open within applications, directly from your EHR, or on our mobile device apps.
Fujifilm Healthcare Americas Corporation
Synapse Mobility Base Package
In Commercial Distribution

  • 00854904006053 ()


  • Radiology picture archiving and communication system workstation

Synapse Pathology - 00854904006039

Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.
Fujifilm Healthcare Americas Corporation
Synapse Pathology Software License
In Commercial Distribution

  • 00854904006039 ()


  • Radiology picture archiving and communication system workstation

Synapse MPR Fusion - 00854904006022

Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. Synapse MPR/Fusion is not intended for Mammography use.
Fujifilm Healthcare Americas Corporation
Synapse MPR Fusion Software License
In Commercial Distribution

  • 00854904006022 ()


  • Radiology picture archiving and communication system workstation

Synapse Cardiology PACS - 00854904006015

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 Radiology PACS - 00854904006008

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

Torch - 00860010685402

No Description
Voximetry, Inc.
V1.2
In Commercial Distribution

  • 00860010685402 ()


  • Nuclear medicine system workstation

3D-RD-S - 00860009926905

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 - 00859873006189

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 - 00859873006172

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 - 00859873006165

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
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