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Device Description : HMS Medical Imaging Suite that provides software applications used to process, d 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.
Device Class : 2
Duns Number: 354140220
Premarket Exempt : No
Prescription Use : Yes
Device Description : The GOLD™ Lx is a client-server distribution image storage and communication sys 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.
Device Class : 1
Duns Number: 354140220
Premarket Exempt : Yes
Prescription Use : No
Device Description : The GOLD™ SMART Workstation is an image management system whose intended use is 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.
Device Class : 1
Duns Number: 354140220
Premarket Exempt : Yes
Prescription Use : No
Device Description : The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorb 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.
Device Class : 1
Duns Number: 354140220
Premarket Exempt : No
Prescription Use : Yes
Device Description : Provides software applications used to process, display, analyze and manage nucl 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.
Device Class : 2
Duns Number: 354140220
Premarket Exempt : No
Prescription Use : Yes
Device Description : HMS Medical Imaging Suite that provides software applications used to process, d 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.
Device Class : 2
Duns Number: 354140220
Premarket Exempt : No
Prescription Use : Yes
Device Description : The GOLD™ Lx is a client-server distribution image storage and communication sys 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.
Device Class : 1
Duns Number: 354140220
Premarket Exempt : Yes
Prescription Use : No
Device Description : Provides software applications used to process, display, analyze and manage nucl 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.
Device Class : 2
Duns Number: 354140220
Premarket Exempt : No
Prescription Use : Yes
Device Description : The GOLD™ SMART Workstation is an image management system whose intended use is 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.
Device Class : 1
Duns Number: 354140220
Premarket Exempt : Yes
Prescription Use : No
Device Description : Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting f 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.
Device Class : 2
Duns Number: 354140220
Premarket Exempt : No
Prescription Use : Yes