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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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
The nordicBrainEx Software is a post-processing application for dynamic MRI data developed with focus on ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for dynamic image analysis and visualization of MRI data, where signal changes over time are analyzed to determine various modality dependent functional parameters. The following algorithms provide the main functional analyses of the application. - BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. - DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain. - DSC: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood volume, blood flow, time to peak, mean transit time and leakage. In addition to these specific functional analyses, the application also provides general visualization tools, a database for data handling, and a reporting feature. This is to ensure that the workflow of the application is optimized to ensure efficiency and high throughput in a clinical environment.
Nordicneurolab AS
2.3
In Commercial Distribution

  • 07090042059015 ()


  • MRI system application software
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 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
HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.6
Not in Commercial Distribution

  • 17540266000029 ()


  • MRI system application software
HeartPro is a web-accessible, self-contained image analysis software application that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. HeartPro specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images.
Medvoxel Diagnostics Inc
4.5
Not in Commercial Distribution

  • 17540266000012 ()


  • MRI system application software
EXAM TABLE W/OUTLET & DRAWER
GF HEALTH PRODUCTS, INC.
4200-DW-WG
In Commercial Distribution

  • M3684200DWWG1 ()


  • Centralized patient monitor
Controller
INTUITIVE SURGICAL, INC.
380707
In Commercial Distribution

  • 00886874116241 ()


  • Surgical planning/navigation-enhancement system
Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838048645 ()
866389

  • Centralized patient monitor
68MCTP VSM6800 UDI BASE MODEL
WELCH ALLYN, INC.
901060
In Commercial Distribution

  • 00732094229219 ()
  • 00732094151060 ()
68MCTP

  • Multiple vital physiological parameter monitoring system, clinical
Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution

  • 00198953001387 ()


  • Ultrasound imaging system application software
Patient Information Center iX
Philips Medical Systems Hsg
Patient Information Center iX
Not in Commercial Distribution

  • 00884838093041 ()
866389

  • Centralized patient monitor
Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software
CBL,4 FIBER LC-LC 75FT
PENTAX OF AMERICA, INC.
92200/75
In Commercial Distribution

  • 04961333242573 ()

  • Length: 75.0 Feet


  • Radiology information system
No Description
ICU MEDICAL, INC.
WW1100
In Commercial Distribution

  • 35019517062667 ()
  • 15019517062663 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1131
In Commercial Distribution

  • 35019517062247 ()
  • 15019517062243 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1130
In Commercial Distribution

  • 35019517062230 ()
  • 15019517062236 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1129
In Commercial Distribution

  • 35019517062223 ()
  • 15019517062229 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1124
In Commercial Distribution

  • 35019517062216 ()
  • 15019517062212 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1140
In Commercial Distribution

  • 35019517054228 ()
  • 15019517054224 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
1102P
In Commercial Distribution

  • 35019517053924 ()
  • 15019517053920 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
1101A
In Commercial Distribution

  • 35019517053894 ()
  • 15019517053890 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220461 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220430 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220362 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220355 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220348 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220331 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220300 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220294 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220287 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220270 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220263 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220256 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220249 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220232 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220225 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220218 ()


  • Portable basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220201 ()


  • Portable basic diagnostic x-ray system, digital
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