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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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CellaVision® Remote Review Software version 5.0.x, Annual license - 07350040973707

The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM instruments with the ability to reclassify cells and sign off slides from another location.
Cellavision AB
CRRS-005001
Not in Commercial Distribution

  • 07350040973707 ()
CRRS-005001

  • Laboratory instrument/analyser application software IVD

CellaVision® Body Fluid Application DM96 - 07350040972564

The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-960099
In Commercial Distribution

  • 07350040972564 ()
CBF-960099

  • Laboratory instrument/analyser application software IVD

CellaVision® Body Fluid Application DM1200 - 07350040972557

The body fluid application automatically locates and presents cell images on cytocentrifuged body fluid preparations.
Cellavision AB
CBF-120099
In Commercial Distribution

  • 07350040972557 ()
CBF-120099

  • Laboratory instrument/analyser application software IVD

Connected OR OS - 07613327311846

No Description
STRYKER CORPORATION
0240060145
In Commercial Distribution

  • 07613327311846 ()
0240-060-145

  • Operating room audiovisual data/device management system application software

Connect OR OS - 07613327311839

No Description
STRYKER CORPORATION
0240060140
In Commercial Distribution

  • 07613327311839 ()
0240-060-140

  • Operating room audiovisual data/device management system application software

Acuitas - 20812125010086

Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution

  • 20812125010086 ()
CP3511

  • Laboratory instrument/analyser application software IVD

CLEWICU - 07290018852002

No Description
CLEW MEDICAL LTD
4.8
In Commercial Distribution

  • 07290018852002 ()


  • Clinical management support software

YO Home Sperm Test - 07290012140983

No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
For I-Phone 5/5S/SE
In Commercial Distribution

  • 07290012140983 ()


  • Motile sperm concentration IVD, kit, imaging, self-testing

nordicMEDIVA - 07090042059084

nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities. nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware or in their own cloud infrastructure. The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data. The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks. The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
3
In Commercial Distribution

  • 07090042059084 ()


  • MRI system application software

nordicMEDIVA - 07090042059077

nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities. nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure. The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data. The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks. The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
2
In Commercial Distribution

  • 07090042059077 ()


  • MRI system application software
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