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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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DYONICS POWER ULTRALIGHT HANDPIECE, SUCTION LEVER, 10 FEET 3 M CORD SERVICE REPLACEMENT
Smith & Nephew, Inc.
7205971SR
In Commercial Distribution

  • 00885556582374 ()
7205971SR

  • Surgical power tool system control unit, line-powered
HAND PACK
Cardinal Health 200, LLC
SOP48HPLAA
In Commercial Distribution

  • 50197106705931 ()
  • 10197106705933 ()
SOP48HPLAA

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

  • 50197106764914 ()
  • 10197106764916 ()
SOPMIHPMCA

  • Decontamination floor mat, single-use
HAND PACK
Cardinal Health 200, LLC
SOP73HPMLB
In Commercial Distribution

  • 50197106702602 ()
  • 10197106702604 ()
SOP73HPMLB

  • 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 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 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
NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Nordicneurolab AS
2.0
In Commercial Distribution

  • 07090042059060 ()


  • 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
No Description
Nordicneurolab AS
1.1
In Commercial Distribution

  • 07090042059046 ()


  • MRI system application software
NordicNeuroLab’s nordicAktiva is a stimulus presentation and workflow software which controls the presentation of stimuli during fMRI exams and has been designed specifically with the clinical user in mind. With an intuitive interface and detailed, easy-to-follow instructions, the user is guided step-by-step through the process of presenting stimuli during MR image acquisition. nordicAktiva runs on the stimulus presentation PC to which the NNL fMRI Hardware System is connected. Through the latter audiovisual stimuli are presented to, and feedback is collected from the patient.
Nordicneurolab AS
1.3
In Commercial Distribution

  • 07090042059022 ()


  • MRI system application software
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