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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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Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007389 ()


  • Radiological PACS software
Encounter Manager
HYLAND LLC
2.X
Not in Commercial Distribution

  • 00850677007303 ()


  • Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007297 ()


  • Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007280 ()


  • Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution

  • 00850677007266 ()


  • Radiological PACS software
Core Server
HYLAND LLC
5.X
Not in Commercial Distribution

  • 00850677007259 ()


  • Radiological PACS software
Media Writer Web
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007242 ()


  • Radiological PACS software
Mod LInk
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007211 ()


  • Radiological PACS software
Image Link Encounter Workflow
HYLAND LLC
1.X
In Commercial Distribution

  • 00850677007204 ()


  • Radiological PACS software
Image Link
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007198 ()


  • Radiological PACS software
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution

  • 00850677007150 ()
PSM2.2.2

  • Radiological PACS software
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client configuration, and the flow of data between modalities and destination DICOM systems. PACSgear
HYLAND LLC
5.1.X
In Commercial Distribution



  • Radiological PACS software
No Description
HYLAND LLC
2.X
Not in Commercial Distribution

  • 00850677007310 ()


  • Radiological PACS software
Web Forms
HYLAND LLC
4.X
Not in Commercial Distribution

  • 00850677007273 ()


  • Radiological PACS software
EHR Gateway
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007235 ()


  • Radiological PACS software
Web Forms, Mod Link Web Forms
HYLAND LLC
3.X
In Commercial Distribution

  • 00850677007228 ()


  • Radiological PACS software
PACS Scan Web
HYLAND LLC
2.X
In Commercial Distribution

  • 00850677007181 ()


  • Radiological PACS software
PACSgear Core Server
HYLAND LLC
4.X
In Commercial Distribution

  • 00850677007167 ()


  • Radiological PACS software
  • Medical image management system
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution

  • 00852426007022 ()


  • CT system application software
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution

  • 00852426007008 ()


  • CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution

  • 00852426007015 ()


  • CT system application software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine leaming models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user's operating system file system (importing DICOM image.dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.8.X
In Commercial Distribution

  • 00628011382184 ()


  • Radiation therapy software
Limbus Contour is a stand-alone software medical device. It is a single purposes cross-platform application for automatic contouring (segmentation) of CT/MRI DICOM images via pre-trained and expert curated machine learning models. The software is intended to be used by trained medical professionals to derive contours for input to radiation treatment planning. The Limbus Contour software segments normal tissues using machine learning models and further post-processing on machine learning model prediction outputs. Limbus Contour does not display or store DICOM images and relies on existing radiotherapy treatment planning systems (TPS) and DICOM image viewers for display and modification of generated segmentations. Limbus Contour interfaces with the user’s operating system file system (importing DICOM image .dcm files and exporting segmented DICOM RT-Structure Set .dcm files).
Limbus Ai Inc.
1.7.X
In Commercial Distribution

  • 00628011382177 ()


  • Radiation therapy software
No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system
No Description
BONRAYBIO CO., LTD.
X QC
In Commercial Distribution

  • 04719874740733 ()


  • Sperm concentration indicator IVD, control
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
3.x
In Commercial Distribution

  • 00882916000530 ()


  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
1.x
In Commercial Distribution

  • 00882916000516 ()
v1.x and v2.0

  • CT system application software
No Description
Circle Cardiovascular Imaging Inc
6.x
In Commercial Distribution

  • 00882916000028 ()


  • MRI system application software
  • CT system application software
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