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Ceevra Reveal 2.0 is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Ceevra Reveal 2.0 mobile application which is used by clinicians for preoperative surgical planning and to support intraoperative decision making. Ceevra Reveal 2.0 includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format. The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making.
Ceevra, Inc.
2.10
In Commercial Distribution
- 00086162500046 ()
- Image segmentation application software
The HoloXR Health Connect is an adjunctive tool to facilitate telecollaboration and consultation to gain the ability of leverage specialized clinicians for collaborative care from any location during surgical and outpatient procedures through real-time transmission of visual and auditory information.
Holoray Inc.
1.0.0
In Commercial Distribution
- G721HXR0 ()
HXR
- Clinical training/education software
Interactive rehabilitation exercise device, prescription use
TIMOCCO USA, INC.
1
In Commercial Distribution
- G629RESTORESKILLSTHERA0 ()
- Virtual-display routine exercise software
myAir (Android)
RESMED CORP.
22246
In Commercial Distribution
- 00840193400122 ()
22246
- Self-care monitoring/reporting software
MYAIR FOR IOS APP
RESMED CORP.
22245
In Commercial Distribution
- 00840193400115 ()
22245
- Self-care monitoring/reporting software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
- Retinal image analysis software
AEYE-DS is a retinal diagnostic software device that incorporates an algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions. Specifically, the AEYE-DS is designed to perform diagnostic screening for the condition of more-than-mild diabetic retinopathy (mtmDR)
Aeye Health, Inc.
AEYE-DS
- Retinal image analysis software
ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Ver 1.3.
Not in Commercial Distribution
- 00015482000042 ()
- Self-care monitoring/reporting software
ReliOn Life is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Ver 1.3.
Not in Commercial Distribution
- 00015482000035 ()
- Self-care monitoring/reporting software
ARK Care Advance is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.
ARKRAY USA, INC.
Ver 2.0.
Not in Commercial Distribution
- 00015482000028 ()
- Self-care monitoring/reporting software