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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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Nio Color 3MP LED - 05415334000063

MDNC-3321 HLX
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000063 ()
K9300328A

  • 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 - 05415334002005

MDNC-2221 EM
Barco NV
MDNC-2221
In Commercial Distribution

  • 05415334002005 ()
K9301654B

  • Radiology picture archiving and communication system workstation

Nio Color 3MP - 05415334001992

MDNC-3421 EM
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001992 ()
K9300347A

  • Radiology picture archiving and communication system workstation

Torch - 00860010685402

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

  • 00860010685402 ()


  • 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

Hermes Medical Imaging Suite - 00859873006158

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
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