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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
The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleared Lucid M1 System (K160442) which assists the user in the acquisition of cerebral blood flow velocity (CBFV) and the occurrence of transient emboli within the blood stream, via the patient’s temporal acoustic windows.
Novasignal Corp.
1.x
Not in Commercial Distribution
- 00850681007122 ()
NA-RBT1
- Noninvasive vascular ultrasound system, line-powered
The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabilizer comfort padding, and registration dots.
Novasignal Corp.
1.x
Not in Commercial Distribution
- 00850681007115 ()
NA-DSP2
- Noninvasive vascular ultrasound support kit
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including patient demographics, images, videos and HL7 messages. It also handles user accounts, security, client configuration, and the folow of data between modalities and destination DICOM systems. PACSgear Enterprise exclusively supports PACSgear client products such as EHR Gateway, Image Link, MDR Video Touch and Web Forms. PACSgear Enterprise Server is not labeled for diagnostic use.
HYLAND LLC
5.2.X
In Commercial Distribution
- 00850677007419 ()
CS.5.2
- Radiological PACS software
PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data including
patient demographics, images, videos, and HL7 messages. It also handles user accounts, security, client
configuration, and the flow of data between modalities and destination DICOM systems. PACSgear
HYLAND LLC
5.1.X
- Radiological PACS software
Image Link Plus supports imaging workflows that do not follow the radiology workflow by providing a pseudo order message to the modality that contains patient and visit information from the Electronic Medical Record (EMR).
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007389 ()
- Radiological PACS software
No Description
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007310 ()
- Radiological PACS software
Encounter Manager
HYLAND LLC
2.X
Not in Commercial Distribution
- 00850677007303 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007297 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007280 ()
- Radiological PACS software
Web Forms
HYLAND LLC
4.X
Not in Commercial Distribution
- 00850677007273 ()
- Radiological PACS software
No Description
HYLAND LLC
3.X
Not in Commercial Distribution
- 00850677007266 ()
- Radiological PACS software
Core Server
HYLAND LLC
5.X
Not in Commercial Distribution
- 00850677007259 ()
- Radiological PACS software
Media Writer Web
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007242 ()
- Radiological PACS software
EHR Gateway
HYLAND LLC
2.X
In Commercial Distribution
- 00850677007235 ()
- Radiological PACS software
Web Forms, Mod Link Web Forms
HYLAND LLC
3.X
In Commercial Distribution
- 00850677007228 ()
- Radiological PACS software
Mod LInk
HYLAND LLC
3.X
In Commercial Distribution
- 00850677007211 ()
- Radiological PACS software
Image Link Encounter Workflow
HYLAND LLC
1.X
In Commercial Distribution
- 00850677007204 ()
- Radiological PACS software
Image Link
HYLAND LLC
2.X
In Commercial Distribution
- 00850677007198 ()
- Radiological PACS software
PACS Scan Web
HYLAND LLC
2.X
In Commercial Distribution
- 00850677007181 ()
- Radiological PACS software
PACSgear Core Server
HYLAND LLC
4.X
In Commercial Distribution
- 00850677007167 ()
- Radiological PACS software
- Medical image management system
PACS Scan Mobile, Android
HYLAND LLC
2.2.X
In Commercial Distribution
- 00850677007150 ()
PSM2.2.2
- Radiological PACS software