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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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KNEE PACK
Cardinal Health 200, LLC
SOP73KPMS4
In Commercial Distribution

  • 50197106191147 ()
  • 10197106191149 ()
SOP73KPMS4

  • Decontamination floor mat, single-use
PLS KNEE ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP69KAKP3
In Commercial Distribution

  • 50197106037902 ()
  • 10197106037904 ()
SOP69KAKP3

  • Decontamination floor mat, single-use
LOWER EXTREMITY PACK
Cardinal Health 200, LLC
SOP29LXM10
In Commercial Distribution

  • 50197106030606 ()
  • 10197106030608 ()
SOP29LXM10

  • Decontamination floor mat, single-use
PK LAPAROSCOPY LN
Cardinal Health 200, LLC
SBA4JLPLNB
In Commercial Distribution

  • 50197106620258 ()
  • 10197106620250 ()
SBA4JLPLNB

  • Decontamination floor mat, single-use
The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images. The image processing provide enhanced quality by reducing the image noise level.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution

  • 07290016836400 ()


  • MRI system application software
KNEE ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP73KNKLA
In Commercial Distribution

  • 50197106842872 ()
  • 10197106842874 ()
SOP73KNKLA

  • Decontamination floor mat, single-use
TOTAL JOINT PACK
Cardinal Health 200, LLC
SOPDHTJWK4
In Commercial Distribution

  • 50197106831630 ()
  • 10197106831632 ()
SOPDHTJWK4

  • Decontamination floor mat, single-use
ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP73APBS1
In Commercial Distribution

  • 50197106827497 ()
  • 10197106827499 ()
SOP73APBS1

  • Decontamination floor mat, single-use
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
nordicDSC is an image analysis module that can be integrated into hospital infrastructure to analyze dynamic susceptibility contrast enhanced (DSC) perfusion data obtained from Magnetic Resonance Imaging (MRI). The product can be deployed on the nordicMEDiVA platform, or as a plugin to other software offerings.
Nordicneurolab AS
23.04
In Commercial Distribution

  • 07090042059053 ()


  • MRI system application software
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