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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
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
Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution
- 00812394021505 ()
40-00296-05
- External defibrillator application software
MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution
- 00812394021499 ()
40-00580-01
- External defibrillator application software
MDLink SW 10.16
Zoll Medical Corporation
400621-046
400621-046
- External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5
Zoll Medical Corporation
XAEDMGR01E
XAEDMGR01E
- External defibrillator application software
Event Reporting and Administrative AED Configuration Software V 2 0 5 0 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01C
In Commercial Distribution
- 00812394020539 ()
XAEDMGR01C
- External defibrillator application software
MDLink SW 10.15
Cardiac Science Corporation
400621-045
In Commercial Distribution
- 00812394020393 ()
400621-045
- External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Cardiac Science Corporation
XAEDMGR01D
In Commercial Distribution
- 00812394020188 ()
XAEDMGR01D
- External defibrillator application software
No Description
Sonova AG
4.3
In Commercial Distribution
- 07613389793987 ()
088-0027-00043
- Audiometric/hearing device software