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CEREC Guide Drill Key ST-L Ø2.8
SIRONA Dental Systems GmbH
6363597
In Commercial Distribution
- E27663635972 ()
- CAD/CAM software
CEREC Guide Drill Key L Ø2.2
SIRONA Dental Systems GmbH
6363589
In Commercial Distribution
- E27663635892 ()
- CAD/CAM software
CEREC Guide Drill Key ST-S Ø2.8
SIRONA Dental Systems GmbH
6362953
In Commercial Distribution
- E27663629532 ()
- CAD/CAM software
CEREC Guide Drill Key S Ø2.2
SIRONA Dental Systems GmbH
6362946
In Commercial Distribution
- E27663629462 ()
- CAD/CAM software
CEREC Guide Drill Key S Ø2.0
SIRONA Dental Systems GmbH
6362938
In Commercial Distribution
- E27663629382 ()
- CAD/CAM software
A digital vision testing system intended as an aid in assessment of visual function in patients. The software delivers algorithms that utilize a visual display which may be a tablet, smart phone, a computer screen, etc.
AMA Optics, Inc.
DiagnosticGame
In Commercial Distribution
- G506DG010 ()
DG01
- Vision self-testing software
No Description
Elekta Solutions AB
AQUA 3.2
In Commercial Distribution
- 07340201500101 ()
- Radiation therapy software
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
OCULOCARE medical AG
3.2.12
In Commercial Distribution
- EOMA32120 ()
- Vision self-testing software
Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data.
Olea S.I.A V1.0 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.
Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images.
Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.
Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.
Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
Olea Medical USA
1.0
In Commercial Distribution
- EOLEOLEASIAV1P00 ()
- Radiological PACS software
Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data.
Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.
Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images.
Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.
Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.
Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.
Olea Medical USA
1.5
In Commercial Distribution
- EOLEAUTOMATIONV1P50 ()
- Radiological PACS software