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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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Thermoguide Workstation - 17340007000833

No Description
Clinical Laserthermia Systems AB
1100-N1
In Commercial Distribution

  • 17340007000833 ()


  • MRI system application software

CARDINAL HEALTH - 10197106355763

KNEE ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOPMIKAMOA
In Commercial Distribution

  • 50197106355761 ()
  • 10197106355763 ()
SOPMIKAMOA

  • Decontamination floor mat, single-use

CARDINAL HEALTH - 10197106353684

KNEE PACK
Cardinal Health 200, LLC
SOPMIKPGRA
In Commercial Distribution

  • 50197106353682 ()
  • 10197106353684 ()
SOPMIKPGRA

  • Decontamination floor mat, single-use

uWS - 06971576834143

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834143 ()


  • MRI system application software

uWS - 06971576834013

MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software

THD Procto Software System - 18033737712389

THD Proctostation is an integrated, modular and expandable one-stop platform for the Colo-Rectal Surgeon/Proctologist, to perform Anorectal manometry, EAUS and High Resolution Anoscopy. It includes: - THD Procto Software - proctology integrated software - Dedicated hardware composed of an All in One professional Personal Compuiter - Insulation Transformer - Procto Trolley with pivoting wheels, brakes and orientable dringging handle
THD SPA
THD Proctostation
In Commercial Distribution

  • 18033737712389 ()
800198

  • Ultrasound imaging system application software

THD Procto Software System - 18033737712341

THD 4K CAM is a very-high-resolution video camera, which allows shooting up to 4K resolution using THD's diagnostic and surgical devices, equipped with a special mechanical connection interface and septic protection sleeve. Capture is done using the THD ProctoSoftware interface, a software suite that allows for the recording of clinical data such as patient records, examination, anorectal canal images, anorectal canal ultrasound images, and anorectal pressure values (anorectal manometry) when used with appropriate medical devices including the purchased video camera.
THD SPA
THD 4K CAM
In Commercial Distribution

  • 18033737712341 ()
800195

  • Ultrasound imaging system application software

Segment CMR - 07350010100027

Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100027 ()


  • MRI system application software

SyMRI - 07340024700078

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software

SyMRI - 07340024700061

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging. SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence. When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution

  • 07340024700061 ()


  • MRI system application software
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