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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 - 00850951007074

TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 27K
Not in Commercial Distribution

  • 00850951007074 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007029

TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 25J
Not in Commercial Distribution

  • 00850951007029 ()
061000-500

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007012

TIMS 2000 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 25J
Not in Commercial Distribution

  • 00850951007012 ()
061000-2000

  • Radiology picture archiving and communication system workstation

TIMS System - 00850951007005

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 25J
Not in Commercial Distribution

  • 00850951007005 ()
061000-2000-SP

  • 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

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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