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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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THD DIGITAL MOBILE LIGHT is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform digital anoscopy, anorectal manometry and Transanal Ultrasound using dedicated hardwares. THD DIGITAL MOBILE LIGHT has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004).
THD SPA
THD DIGITAL MOBILE LIGHT
In Commercial Distribution

  • 68051887046715 ()
800320

  • Ultrasound imaging system application software
THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry and Transanal Ultrasound. THD DIGITAL MOBILE ADVANCED has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes, THD Anopress (transportable anorectal manometer) for anorectal manometry and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ADVANCED
In Commercial Distribution

  • 68051887043325 ()
800309

  • Ultrasound imaging system application software
THD DIGITAL MOBILE ECOGRAPHY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry (optional) and Transanal Ultrasound. THD DIGITAL MOBILE ECOGRAPHY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ECOGRAPHY
In Commercial Distribution

  • 68051887043318 ()
800308

  • Ultrasound imaging system application software
THD DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry. THD DIGITAL MOBILE MANOMETRY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and THD Anopress (transportable anorectal manometer) for anorectal manometry.
THD SPA
THD DIGITAL MOBILE MANOMETRY
In Commercial Distribution

  • 68051887043301 ()
800307

  • Ultrasound imaging system application software
THD DIGITAL MOBILE is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry (optional) and Transanal Ultrasound (optional). THD DIGITAL MOBILE has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004) and a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes.
THD SPA
THD DIGITAL MOBILE
In Commercial Distribution

  • 68051887043295 ()
800306

  • Ultrasound imaging system application software
KNEE ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP23KAMAA
In Commercial Distribution

  • 50197106768691 ()
  • 10197106768693 ()
SOP23KAMAA

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

  • 50197106764914 ()
  • 10197106764916 ()
SOPMIHPMCA

  • 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
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