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cNeuro™ cDAT is intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for display, processing, and reporting of Nuclear Medicine Imaging data.
cNeuro™ cDAT enables visual evaluation and quantification of 123 Ioflupane (DaTscan™) images. The software enables automated quantification of tracer uptake and comparison with the corresponding tracer uptake in healthy subjects as provided by normal population databases of 123 Ioflupane (DaTscan™) images. cNeuro™ cDAT assists in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease or Dementia with Lewy Bodies (DLB).
cNeuro cDAT has not been demonstrated to improve 123 ioflupane reader performance for distinguishing positive from negative patients. This device should not be used to deviate from 123 ioflupane dosing and administration instructions. Refer also to 123 ioflupane prescribing information for instructions.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070845012 ()
- Radiology DICOM image processing application software
cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.
The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.
cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration.
PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy.
cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.
Combinostics Oy
1.0.x
In Commercial Distribution
- 06430070844015 ()
- Radiology DICOM image processing application software
https://www.combinostics.com/cmri/
Combinostics Oy
2.0.X
In Commercial Distribution
- 06430070841021 ()
- Radiology DICOM image processing application software
No Description
PaloDEx Group Oy
6.x
In Commercial Distribution
- 06430035872367 ()
213248
- Stationary panoramic/tomographic dental x-ray system, digital
No Description
PaloDEx Group Oy
11.x
In Commercial Distribution
- 06430035872350 ()
213183
- Stationary panoramic/tomographic dental x-ray system, digital
No Description
Tilite
TiLite X
In Commercial Distribution
- 00853316008129 ()
- Push-rim manual wheelchair, non-bariatric
No Description
Tilite
Aero X
In Commercial Distribution
- 00853316008068 ()
- Push-rim manual wheelchair, non-bariatric
Aer X is a portable Oxygen concentrator
3B MEDICAL, INC.
Aer X
In Commercial Distribution
- 00853041003000 ()
021000M
- Mobile/portable oxygen concentrator
The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution
- 00851147007120 ()
- Radiation therapy software
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution
- 00852426007022 ()
- CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution
- 00852426007015 ()
- CT system application software
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution
- 00852426007008 ()
- CT system application software
Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
GLOOKO, INC.
18.x
In Commercial Distribution
- 00855093008019 ()
- Clinical management support software
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution
- 00855093008002 ()
- Clinical management support software
Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution
- 00860002545714 ()
- Ultrasound imaging system application software
Acuvision X is a surgical microscope intended for the illumination and magnification of the surgical area during surgical procedures (except ophthalmic surgeries).
Changzhou Sifary Medical Technology Co., Ltd.
Acuvision X
In Commercial Distribution
- 06941877821456 ()
5380009
- General-purpose surgical microscope
physIQ convenience kit including mobile relay device pre-loaded with physIQ monitoring software, biosensors, and skin preparation materials.
PHYSIQ, INC
Model X
In Commercial Distribution
- 00850023120212 ()
- Electrocardiography telemetric monitoring system
The Via X Anti-Gravity Treadmill is intended to be a used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support.
Lifeward CA, Inc.
Via X
In Commercial Distribution
- 00850022788031 ()
- Pneumatic-support treadmill
The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support
Lifeward CA, Inc.
Fit X
In Commercial Distribution
- 00850022788017 ()
- Pneumatic-support treadmill
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution
- 00850010298146 ()
ELEFT
- Cardiopulmonary physiological parameter analysis software