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Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.
Fujifilm Healthcare Americas Corporation
Synapse Cardiology PACS Software License
In Commercial Distribution
- 00854904006015 ()
- Radiology picture archiving and communication system workstation
Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts of image information that are handled by their offices each day.
Fujifilm Healthcare Americas Corporation
Synapse Radiology PACS Software License
In Commercial Distribution
- 00854904006008 ()
- Radiology picture archiving and communication system workstation
ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWS-900A
In Commercial Distribution
- 04987670101014 ()
- Ultrasound imaging system workstation
ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
TUW-U001S
In Commercial Distribution
- 04987670100796 ()
- Ultrasound imaging system workstation
Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration.
Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.
Focal Healthcare Inc
2.0
In Commercial Distribution
- 00628055858010 ()
- Radiology picture archiving and communication system workstation
Fusion Bx is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer.
Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate.
Focal Healthcare Inc
1.1
In Commercial Distribution
- 00628055858003 ()
- Radiology picture archiving and communication system workstation
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case-related non-image documents, archives them as DICOM data, and serves as a vendor-neutrall archive. It supports the physician in diagnosis. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
MedDream is a HTML based package for PACS server which is designed to aid professionals in every day's decision-making process, connecting all the medical data into a unified and fast performing network. MedDream ensures a fast and reliable way to search, present and analyze the medical data (images and video files) on various devices: computers, smart phones, tablets and so forth.
MEDDREAM UAB
7.5.1
In Commercial Distribution
- 04779049590105 ()
NA
- Radiology picture archiving and communication system workstation
4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWP-100A
Not in Commercial Distribution
- 04987670102370 ()
- Ultrasound imaging system workstation
No Description
Voximetry, Inc.
V1.2
In Commercial Distribution
- 00860010685402 ()
- Nuclear medicine system workstation
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 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
P60
- Nuclear medicine system workstation
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
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
- 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
- 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
The Falcon MD is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
ICAT SOLUTIONS LTD
HOROS MOBILE
In Commercial Distribution
- 05070002336815 ()
- Radiology picture archiving and communication system workstation
The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both 2D and 3D image visualization tools for CT and MRI scans from different makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. Horos MD™ conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System). The Horos MD™ software device runs on the macOS X platform, taking advantage of its optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc. The user interface of the software follows Apple's Human Interface Guidelines (HIG) in order to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
ICAT SOLUTIONS LTD
HOROS MD
In Commercial Distribution
- 05070002336808 ()
- Radiology picture archiving and communication system workstation
MDCC-4430 NC
Barco NV
MDCC-4430
In Commercial Distribution
- 05415334025981 ()
K9301628A
- Radiology picture archiving and communication system workstation
MDCC-6530 NC
Barco NV
MDCC-6530
In Commercial Distribution
- 05415334025974 ()
K9301638A
- Radiology picture archiving and communication system workstation
MDNC-2123 NEU MKII
Barco NV
MDNC-2123
Not in Commercial Distribution
- 05415334002623 ()
K9300333B
- Radiology picture archiving and communication system workstation
MDNC-2123 EM BL MKII
Barco NV
MDNC-2123
In Commercial Distribution
- 05415334002616 ()
K9300332B
- Radiology picture archiving and communication system workstation
MDNC-2123 DE WP MKII
Barco NV
MDNC-2123
In Commercial Distribution
- 05415334002609 ()
K9300331B
- Radiology picture archiving and communication system workstation
MDNC-2123 DE WH MKII
Barco NV
MDNC-2123
In Commercial Distribution
- 05415334002357 ()
K9300330B
- Radiology picture archiving and communication system workstation
MDCC-4430
Barco NV
MDCC-4430
In Commercial Distribution
- 05415334002340 ()
K9301626A
- Radiology picture archiving and communication system workstation
MDCC-6530
Barco NV
MDCC-6530
In Commercial Distribution
- 05415334002326 ()
K9301636A
- Radiology picture archiving and communication system workstation
accessories for image enhancement in diagnostic displays
Barco NV
2.X.X.X
In Commercial Distribution
- 05415334002050 ()
K9308260
- Radiology picture archiving and communication system workstation
MDNC-2123 DE WP
Barco NV
MDNC-2123
Not in Commercial Distribution
- 05415334002029 ()
K9300331A
- Radiology picture archiving and communication system workstation
MDNC-2221 EM
Barco NV
MDNC-2221
In Commercial Distribution
- 05415334002005 ()
K9301654B
- Radiology picture archiving and communication system workstation
MDNC-3421 EM
Barco NV
MDNC-3421
In Commercial Distribution
- 05415334001992 ()
K9300347A
- Radiology picture archiving and communication system workstation
MDNC-3421 DE
Barco NV
MDNC-3421
In Commercial Distribution
- 05415334001916 ()
K9300346A
- Radiology picture archiving and communication system workstation
MDNC-3421 HLX
Barco NV
MDNC-3421
In Commercial Distribution
- 05415334001695 ()
K9300345A
- Radiology picture archiving and communication system workstation
MDNC-3421 DE NC
Barco NV
MDNC-3421
In Commercial Distribution
- 05415334001688 ()
K9300344A
- Radiology picture archiving and communication system workstation
No Description
Barco NV
MDMG-5121
Not in Commercial Distribution
- 05415334001589 ()
K9300508A
- Radiology picture archiving and communication system workstation
MDMG-5221 CB
Barco NV
MDMG-5221
Not in Commercial Distribution
- 05415334001572 ()
K9300521B
- Radiology picture archiving and communication system workstation
MDMG-5221
Barco NV
MDMG-5221
Not in Commercial Distribution
- 05415334001565 ()
K9300520B
- Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCG-5121
Not in Commercial Distribution
- 05415334001558 ()
K9301500B
- Radiology picture archiving and communication system workstation
MDNG-5121 CB (MA)
Barco NV
MDNG-5121
Not in Commercial Distribution
- 05415334001541 ()
K9300266C
- Radiology picture archiving and communication system workstation
MDMG-5221 CB
Barco NV
MDMG-5221
Not in Commercial Distribution
- 05415334001534 ()
K9300521A
- Radiology picture archiving and communication system workstation
MDMG-5221 BB
Barco NV
MDMG-5221
Not in Commercial Distribution
- 05415334001527 ()
K9300520A
- Radiology picture archiving and communication system workstation