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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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Hybrid 3D - 00859873006042

Provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function.
Hermes Medical Solutions AB
1.0
Not in Commercial Distribution

  • 00859873006042 ()
P54

  • Nuclear medicine system workstation

OLINDA/EXM - 00859873006035

The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a result of administering any radionuclide and to calculate effective whole-body dose. This is dependent on input data regarding bio distribution being supplied to the application.
Hermes Medical Solutions AB
2
In Commercial Distribution

  • 00859873006035 ()


  • Nuclear medicine system workstation

GOLD SMART WS - 00859873006028

The GOLD™ SMART Workstation is an image management system whose intended use is to retrieve, archive, and distribute medical images and data from and to all vendor modalities and hospital information systems.
Hermes Medical Solutions AB
v1.7
Not in Commercial Distribution

  • 00859873006028 ()


  • Radiology picture archiving and communication system workstation

GOLD Lx - 00859873006011

The GOLD™ Lx is a client-server distribution image storage and communication system whose intended use is to provide solutions for hospital and related institutions/sites, which will store, retrieve, and distribute medical images and data from vendor modalities and hospital information systems.
Hermes Medical Solutions AB
1.6
Not in Commercial Distribution

  • 00859873006011 ()


  • Radiology picture archiving and communication system workstation

HMS Medical Imaging Suite - 00859873006004

HMS Medical Imaging Suite that 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
5.6
Not in Commercial Distribution

  • 00859873006004 ()


  • Nuclear medicine system workstation

Synapse Enterprise Viewer - 00854904006060

Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting, rendering on the server component and communication and display of DICOM and non-DICOM images as well as reports.
Fujifilm Healthcare Americas Corporation
Synapse Enterprise Viewer
In Commercial Distribution

  • 00854904006060 ()


  • Radiology picture archiving and communication system workstation

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

TIMS System - 00850059977415

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 53S
In Commercial Distribution

  • 00850059977415 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977408

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 S 53S
In Commercial Distribution

  • 00850059977408 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977392

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 53S
In Commercial Distribution

  • 00850059977392 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977385

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 53S
In Commercial Distribution

  • 00850059977385 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977378

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 53S
In Commercial Distribution

  • 00850059977378 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977361

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 52R
In Commercial Distribution

  • 00850059977361 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977354

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 S 52R
In Commercial Distribution

  • 00850059977354 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977347

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 52R
In Commercial Distribution

  • 00850059977347 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977330

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 52R
In Commercial Distribution

  • 00850059977330 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977323

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 52R
In Commercial Distribution

  • 00850059977323 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977316

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 52S
In Commercial Distribution

  • 00850059977316 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977309

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 52S
In Commercial Distribution

  • 00850059977309 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977293

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 52S
In Commercial Distribution

  • 00850059977293 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977286

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 S 52S
In Commercial Distribution

  • 00850059977286 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977279

TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 52S
In Commercial Distribution

  • 00850059977279 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977262

TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 S 51R
Not in Commercial Distribution

  • 00850059977262 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977255

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 51R
Not in Commercial Distribution

  • 00850059977255 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977248

TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES 51R
Not in Commercial Distribution

  • 00850059977248 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977231

TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS 2000 FEES-L 51R
Not in Commercial Distribution

  • 00850059977231 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation
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