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Cleerly Labs is used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software provides tools for the measurement and visualization of coronary arteries.
CLEERLY, INC.
v2.0
In Commercial Distribution
- 00860001924114 ()
- Radiological PACS software
Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution
- 00860001790832 ()
- Neuromuscular rehabilitation software
Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution
- 00860001790825 ()
- Neuromuscular rehabilitation software
Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is intended to be used in the home for the physical rehabilitation of ambulatory adults with walking impairments from Parkinson's disease.
Medrhythms, Inc.
0050
In Commercial Distribution
- 00860001790818 ()
- Neuromuscular rehabilitation software
InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution
- 00860001790801 ()
- Neuromuscular rehabilitation software
CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.
CNS Vital Signs, LLC
1.1.4
In Commercial Distribution
- 00860013886134 ()
- Psychological assessment software
CNS Vital Signs cognitive testing installed local software platform. A set of cognitive tests and clinical questionnaires administered in office without an internet connection.
CNS Vital Signs, LLC
4.0.107
In Commercial Distribution
- 00860013886110 ()
- Psychological assessment software
CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in office or remotely.
CNS Vital Signs, LLC
2.0.6
In Commercial Distribution
- 00860013886103 ()
- Psychological assessment software
eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution
- 00866994000255 ()
- Radiological PACS software
eRAD PACS Evolution
Erad, Inc.
8.0
In Commercial Distribution
- 00866994000224 ()
- Radiological PACS software
eRAD PACS v7.2
Erad, Inc.
7.2
In Commercial Distribution
- 00866994000200 ()
- Radiological PACS software
Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution
- 00866562000229 ()
91326
- Radiation therapy software
No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution
- 00860011042105 ()
- Cognitive assessment software
NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is designed to address a patient’s difficulty with eye movement and the integration of visual information. The therapy re-trains the patient’s ability to scan the environment, re-integrate left and right vision, and make the most of their remaining visual field. NeuroeyeCoach is self-adaptive and adjusts the task difficulty to the patient's deficit and stage of recovery while encouraging eye movement efficiency.
Novavision, Inc.
NEC 2.00
In Commercial Distribution
- 00860010599716 ()
- Vision training software
VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
Novavision, Inc.
VRT 7.0
In Commercial Distribution
- 00860010599709 ()
- Vision training software
No Description
Oncospace, Inc.
System
In Commercial Distribution
- 00860004284901 ()
- Radiation therapy software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia
Luminopia, Inc.
2.0
In Commercial Distribution
- 00860007887123 ()
- Vision training software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 90 Day
Luminopia, Inc.
2.0
In Commercial Distribution
- 00860007887116 ()
- Vision training software
Prescription Digital Therapeutic for the Treatment of Pediatric Amblyopia - 30 Day
Luminopia, Inc.
2.0
In Commercial Distribution
- 00860007887109 ()
- Vision training software
No Description
Qr8 Health Inc
CHR-COG-20
In Commercial Distribution
- 00860007318795 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-W20
In Commercial Distribution
- 00860007318788 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-23
In Commercial Distribution
- 00860007318771 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution
- 00860007318764 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-22
In Commercial Distribution
- 00860007318757 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution
- 00860007318740 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-10
Not in Commercial Distribution
- 00860007318733 ()
- Cognitive assessment software
3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution
- 00860007402326 ()
- Radiation therapy software
3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution
- 00860007402319 ()
- Radiation therapy software
ProKnow DS is a cloud-based RT-PACS to archive, inspect, analyze, and interact with radiation therapy patient data for retrospective studies, prospective analysis, and clinical decision support.
PROKNOW, LLC
1.0
In Commercial Distribution
- 00860000358705 ()
- Radiological PACS software
The DynaCAD 3 software consists of the MR Analysis Server software and the viewer workstation software.
The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD Advanced PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.
The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.
DynaCAD 3 software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD 3 software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates easily into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.
Icad, Inc.
3.5
In Commercial Distribution
- 00858012005786 ()
D4D0185
- Radiological PACS software