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CEREC Guide Drill Key M Ø4.1
SIRONA Dental Systems GmbH
6371905
In Commercial Distribution
- E27663719052 ()
- CAD/CAM software
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution
- B80721 ()
2
- Radiological PACS software
QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution
- B80731 ()
3
- Radiological PACS software
QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution
- B80711 ()
1
- Radiological PACS 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
HiPAL Pro is a mobile application that presents a short, language independent, cognitive assessment. HiPAL Pro is self-
administered but must be prescribed and must have results evaluated by a licensed medical professional. Moreover, HiPAL Pro must be initiated and supervised
by professionals experienced in the use of cognitive assessment tools. The output score is aimed at screening for as well
as aiding diagnosis and monitoring of Alzheimer’s disease (AD) and Cognitive Impairment. Scores are reviewed and
interpreted by a licensed medical professional through an accompanying web portal.
GT DIAGNOSTICS (UK) LIMITED
1.0.1
In Commercial Distribution
- G527GTDHIPALPRO01V1010 ()
GTD-HiPALPro-01
- Cognitive assessment software
Ophthalmic Photography
OPHTHALMIC LABS INC
5.0
In Commercial Distribution
- G62650 ()
- Camera application 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 Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Medical USA
3.0
In Commercial Distribution
- EOLEOLEASPHEREV3P01 ()
- Radiological PACS software
Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Medical USA
2.3
Not in Commercial Distribution
- EOLEOLEASPHEREV2P31 ()
- Radiological PACS software