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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ClearRead CT Server
Riverain Technologies, Inc.
5.6.2
In Commercial Distribution

  • M722C22347V213240 ()


  • Radiological PACS software
ClearRead CT Server
Riverain Technologies, Inc.
5.6.1
In Commercial Distribution

  • M722C22311V213240 ()


  • Radiological PACS software
ClearRead CT Server
Riverain Technologies, Inc.
5.6.0
In Commercial Distribution

  • M722C22276V213240 ()


  • Radiological PACS software
The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.
Fujifilm Healthcare Americas Corporation
4.X.X
In Commercial Distribution

  • 00869047000431 ()


  • Radiological PACS software
The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Panther treatment planning system allows radiation physicians, physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases.
Prowess, Inc.
version 5.51
Not in Commercial Distribution

  • 00868603000236 ()


  • Radiation therapy software
A software application that allows post-capture positioning and joining of individual images, to produce an additional composite image for a two-dimensional image review.
OSKO, INC.
Smart Stitching
In Commercial Distribution

  • 00869126000451 ()


  • Radiological PACS software
No Description
INTOUCH TECHNOLOGIES, INC.
InTouch Imaging
In Commercial Distribution

  • 00868772000174 ()


  • Radiological PACS software
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 17
Cercare Medical A/S
17
In Commercial Distribution

  • 05745000308279 ()


  • Radiological PACS software
Cercare Medical Neurosuite with Capillary Function ver. 17
Cercare Medical A/S
17
In Commercial Distribution

  • 05745000308262 ()


  • Radiological PACS software
Cercare Medical Neurosuite ver. 17
Cercare Medical A/S
17
In Commercial Distribution

  • 05745000308255 ()


  • Radiological PACS software
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 16
Cercare Medical A/S
16
In Commercial Distribution

  • 05745000308224 ()


  • Radiological PACS software
Cercare Medical Neurosuite with Capillary Function ver. 16
Cercare Medical A/S
16
In Commercial Distribution

  • 05745000308217 ()


  • Radiological PACS software
Cercare Medical Neurosuite ver. 16
Cercare Medical A/S
16
In Commercial Distribution

  • 05745000308200 ()


  • Radiological PACS software
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 15
Cercare Medical A/S
15
In Commercial Distribution

  • 05745000308170 ()


  • Radiological PACS software
Cercare Medical Neurosuite with Capillary Function ver. 15
Cercare Medical A/S
15
In Commercial Distribution

  • 05745000308163 ()


  • Radiological PACS software
Cercare Medical Neurosuite ver. 15
Cercare Medical A/S
15
In Commercial Distribution

  • 05745000308156 ()


  • Radiological PACS software
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 14
Cercare Medical A/S
14
In Commercial Distribution



  • Radiological PACS software
Cercare Medical Neurosuite with Capillary Function ver. 14
Cercare Medical A/S
14
In Commercial Distribution



  • Radiological PACS software
Cercare Medical Neurosuite ver. 14
Cercare Medical A/S
14
In Commercial Distribution



  • Radiological PACS software
No Description
Cercare Medical A/S
2023-06-01
Not in Commercial Distribution

  • 05745000308071 ()


  • Radiological PACS software
No Description
Cercare Medical A/S
2023-06-01
Not in Commercial Distribution

  • 05745000308064 ()


  • Radiological PACS software
No Description
Cercare Medical A/S
2023-06-01
Not in Commercial Distribution

  • 05745000308057 ()


  • Radiological PACS software
Cercare Medical Neurosuite with Capillary Function, release 2023-02-01 and prior
Cercare Medical A/S
CMN with Capillary Function (MR)
Not in Commercial Distribution

  • 05745000308019 ()


  • Radiological PACS software
Cercare Medical Neurosuite release 2023-02-01 and prior
Cercare Medical A/S
Cercare Medical Neurosuite
Not in Commercial Distribution

  • 05745000308002 ()


  • Radiological PACS software
The Anatomy Design software is intended to be used for designing dental restorations for use by dentists for patients.The Anatomy Design software can be operated by trained dental practitioners and dental technicians.The Anatomy Design software is to be used in standard dentist clinics and dental laboratories
3shape A/S
2016-1
Not in Commercial Distribution

  • 05902768365115 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
2016-1
Not in Commercial Distribution

  • 05902768365092 ()


  • CAD/CAM software
Automate is intended to generate design and manufacturing files for dental restorative prosthetics and dental appliances. Automate can be used for the following: - Dental prosthetic restorations - Dental appliances
3shape A/S
R2b
In Commercial Distribution

  • 05902729754019 ()


  • CAD/CAM software
Automate automatically generates designs and manufacturing files for certain dental CAD orders.
3shape A/S
R1.3
In Commercial Distribution

  • 05902729753913 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.2.x
In Commercial Distribution

  • 05902729753630 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
2018-1
Not in Commercial Distribution

  • 05902729752473 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
2017-1
Not in Commercial Distribution

  • 05902729752251 ()


  • CAD/CAM software
The Puffin service is intended to aid in the design of dental restorative prosthetics.
3shape A/S
R1.0
Not in Commercial Distribution

  • 05902729753531 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.1.x
Not in Commercial Distribution

  • 05902729753500 ()


  • CAD/CAM software
Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion.
3shape A/S
88.x.y
Not in Commercial Distribution

  • 05902729752794 ()


  • CAD/CAM software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
IMPACT APPLICATIONS, INC.
4
In Commercial Distribution

  • 00864127000349 ()


  • Cognitive assessment software
No Description
IMPACT APPLICATIONS, INC.
1
In Commercial Distribution

  • 00864127000332 ()


  • Cognitive assessment software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
1
Not in Commercial Distribution

  • 00864127000325 ()


  • Cognitive assessment software
Web-based dental Picture Archiving and Communications System (PACS)
REALCLOUD IMAGING, INC.
1
In Commercial Distribution

  • 00864058000302 ()


  • Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
IMORGON MEDICAL LLC
Imorgon Report Accelerator 1.4
In Commercial Distribution

  • 00863670000349 ()


  • Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
IMORGON MEDICAL LLC
Imorgon iSite integrator 14.1
In Commercial Distribution

  • 00863670000332 ()


  • Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
IMORGON MEDICAL LLC
Imorgon Server 2.2
In Commercial Distribution

  • 00863670000325 ()


  • Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
IMORGON MEDICAL LLC
Imorgon LaunchPad 2.5
In Commercial Distribution

  • 00863670000318 ()


  • Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
IMORGON MEDICAL LLC
Imorgon View/Workstation 2.7
In Commercial Distribution

  • 00863670000301 ()


  • Radiological PACS software
Final software release for UDI-DI: T-2022.03. Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
SYNOPSYS, INC.
S-2021.06 onwards
Not in Commercial Distribution

  • 00863520000390 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
R-2020.09
Not in Commercial Distribution

  • 00863520000376 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.03
Not in Commercial Distribution

  • 00863520000369 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.06
Not in Commercial Distribution

  • 00863520000352 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
N-2018.03
Not in Commercial Distribution

  • 00863520000321 ()


  • Radiological PACS software
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000315 ()


  • Radiation therapy software
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