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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Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular 2.1
In Commercial Distribution

  • 00884838075214 ()
98960612207X

  • Radiology picture archiving and communication system workstation
Philips IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
8.x
In Commercial Distribution

  • 00884838074804 ()
837509

  • Radiology picture archiving and communication system workstation
IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Philips Healthcare Informatics, Inc.
IntelliSpace PACS - 4
In Commercial Distribution

  • 00884838074781 ()
837507

  • Radiology picture archiving and communication system workstation
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
1.x
In Commercial Distribution

  • 00884838074743 ()


  • Radiology picture archiving and communication system workstation
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 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
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
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
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
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
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