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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AFFINITY is a software application used to process, display, analyse 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
2.0
Not in Commercial Distribution



  • Nuclear medicine system workstation
AFFINITY is a software application used to process, display, analyse 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
1.0
Not in Commercial Distribution

  • 00859873006134 ()


  • Nuclear medicine system workstation
Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™ workflow consists of the following steps: • SPECT/CT or PET/CT DICOM data loading from the data manager GOLD or PACS • Registration of different time-points to a common reference study • Generation and integration of voxel-level time-activity curves • Voxel-level absorbed dose calculation using a Monte Carlo-method • Saving of the absorbed dose-map back to GOLD or PACS in DICOM format. Intended Use: The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application. Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes. Warning! The Voxel Dosimetry™ is only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose.
Hermes Medical Solutions AB
1.0
In Commercial Distribution

  • 00859873006110 ()


  • Nuclear medicine system workstation
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
v2.0
In Commercial Distribution

  • 00859873006080 ()


  • Radiology picture archiving and communication system workstation
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. UDI = 00859873006073 applies to Hybrid 3D version 2.x and 3.x.
Hermes Medical Solutions AB
2.2 and 3.0
In Commercial Distribution

  • 00859873006073 ()
P54

  • Nuclear medicine system workstation
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
2
In Commercial Distribution



  • Radiology picture archiving and communication system workstation
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
5.7
Not in Commercial Distribution

  • 00859873006059 ()


  • Nuclear medicine system workstation
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
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
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
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 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
ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc.
FUJIFILM CORPORATION
MIS-1000
In Commercial Distribution

  • 04547410345438 ()


  • Radiology picture archiving and communication system workstation
The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation
No Description
SAMSUNG MEDISON CO., LTD.
USO-SYCPK10/SW
In Commercial Distribution

  • 08809944935018 ()


  • Ultrasound imaging system workstation
No Description
SINGULAR HEALTH PTY LTD
3Dicom MD
In Commercial Distribution

  • 09309000371006 ()
v3.5.2

  • Radiology picture archiving and communication system workstation
No Description
aycan Digitalsysteme GmbH
from v4.02.002
In Commercial Distribution

  • 04260476510052 ()


  • Radiology picture archiving and communication system workstation
No Description
aycan Digitalsysteme GmbH
v2
In Commercial Distribution

  • 04260476510045 ()


  • Radiology picture archiving and communication system workstation
No Description
aycan Digitalsysteme GmbH
v1 (US)
In Commercial Distribution

  • 04260476510038 ()


  • Radiology picture archiving and communication system workstation
No Description
aycan Digitalsysteme GmbH
v3
In Commercial Distribution

  • 04260476510021 ()


  • Radiology picture archiving and communication system workstation
No Description
aycan Digitalsysteme GmbH
v3
Not in Commercial Distribution

  • 04260476510014 ()


  • Radiology picture archiving and communication system workstation
CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning.
CHILI GmbH
4.86.0
In Commercial Distribution

  • 04260456230178 ()


  • Radiology picture archiving and communication system workstation
CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning.
CHILI GmbH
4.84.0
In Commercial Distribution

  • 04260456230161 ()


  • Radiology picture archiving and communication system workstation
CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning.
CHILI GmbH
4.82.0
In Commercial Distribution

  • 04260456230154 ()


  • Radiology picture archiving and communication system workstation
CHILI PACS is a picture archiving and communication system with image processing functions to support physicians in diagnosis and treatment planning.
CHILI GmbH
4.80.0
In Commercial Distribution

  • 04260456230147 ()


  • Radiology picture archiving and communication system workstation
No Description
CHILI GmbH
4.78.0
In Commercial Distribution

  • 04260456230130 ()


  • Radiology picture archiving and communication system workstation
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4 DR Virtualized
In Commercial Distribution

  • 00840682152082 ()


  • Nuclear medicine system workstation
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4.1450
In Commercial Distribution

  • 00840682147545 ()


  • Nuclear medicine system workstation
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Viewer
In Commercial Distribution

  • 00840682141109 ()


  • Ultrasound imaging system workstation
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4.0
In Commercial Distribution

  • 00840682109819 ()


  • Nuclear medicine system workstation
AW 4.7 Medical device
GE MEDICAL SYSTEMS
4.7
In Commercial Distribution

  • 00840682102278 ()


  • Radiology picture archiving and communication system workstation
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
4.1
In Commercial Distribution

  • 00840682134897 ()


  • Nuclear medicine system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Convergent Imaging Solutions Incorporated
7-4-1-PX
In Commercial Distribution

  • B843UNISYN7410 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-4-PX
In Commercial Distribution

  • B843UNISYN7340 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-3-PX
In Commercial Distribution

  • B843UNISYN7330 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-2-PX
In Commercial Distribution

  • B843UNISYN7320 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-1-PX
Not in Commercial Distribution

  • B843UNISYN7310 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-2-1-PX
Not in Commercial Distribution

  • B843UNISYN7210 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-1-1-PX
Not in Commercial Distribution

  • B843UNISYN7110 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-6-PX
Not in Commercial Distribution

  • B843UNISYN6260 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-5-PX
Not in Commercial Distribution

  • B843UNISYN6250 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-4-PX
Not in Commercial Distribution

  • B843UNISYN6240 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-3-PX
Not in Commercial Distribution

  • B843UNISYN6230 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-2-PX
Not in Commercial Distribution

  • B843UNISYN6220 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-2-1-PX
Not in Commercial Distribution

  • B843UNISYN6210 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
6-1-1-PX
Not in Commercial Distribution

  • B843UNISYN6110 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
5-6-1-PX
Not in Commercial Distribution

  • B843UNISYN5610 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
5-5-2-PX
Not in Commercial Distribution

  • B843UNISYN5520 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
5-5-1-PX
Not in Commercial Distribution

  • B843UNISYN5510 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
5-4-1-PX
Not in Commercial Distribution

  • B843UNISYN5410 ()


  • Radiology picture archiving and communication system workstation
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