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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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TIMS System - 00850059977071

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 50P
Not in Commercial Distribution

  • 00850059977071 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977064

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 50O
Not in Commercial Distribution

  • 00850059977064 ()
061000-FEES

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977057

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 50O
Not in Commercial Distribution

  • 00850059977057 ()
061000-FEES-L

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977040

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 50O
Not in Commercial Distribution

  • 00850059977040 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977033

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 50O
Not in Commercial Distribution

  • 00850059977033 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977026

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 50O
Not in Commercial Distribution

  • 00850059977026 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977019

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 49O
Not in Commercial Distribution

  • 00850059977019 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation

TIMS System - 00850059977002

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 49O
Not in Commercial Distribution

  • 00850059977002 ()
061000-FEES-L

  • Radiology picture archiving and communication 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

Coronis Fusion 4 MP - 05415334025981

MDCC-4430 NC
Barco NV
MDCC-4430
In Commercial Distribution

  • 05415334025981 ()
K9301628A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 6 MP - 05415334025974

MDCC-6530 NC
Barco NV
MDCC-6530
In Commercial Distribution

  • 05415334025974 ()
K9301638A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002623

MDNC-2123 NEU MKII
Barco NV
MDNC-2123
Not in Commercial Distribution

  • 05415334002623 ()
K9300333B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002616

MDNC-2123 EM BL MKII
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334002616 ()
K9300332B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002609

MDNC-2123 DE WP MKII
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334002609 ()
K9300331B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002357

MDNC-2123 DE WH MKII
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334002357 ()
K9300330B

  • Radiology picture archiving and communication system workstation
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