EDENTA ETABLISSEMENT TM10.314.009 EDENTA

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.

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.

ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.

Burr, Oval, 10 flute, 3.0mm

This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

MaxFOV 2 Application Container for Smart Subscription

Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

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.

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.

ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.

The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.