BoneView Detection function is a software-only device designed to assist clinicians in the interpretation of X-ray radiographs. BoneViewDetection function is a software as a service that takes as an input X-ray radiographs in DICOM format, processes them using artificial intelligence (deep learning), and provides as an output the detection of anomalies.
BoneView detects the following:
- Fracture
- Dislocation
- Effusion
- Lesion
BoneView takes in consideration the following areas:
- Limbs
- Pelvis
- Ribs
- Dorsolumbar Spine3
BoneView Output
Discover Gleamer BoneView
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- CR / DX / DR Exams
- A body part algorithm will define which images can be processed
- The result files provided by BoneView are in an additional series in the original study including:
- The “Summary Table”: a Summary synthesizing the results of BoneView at the study level. The table includes the following information:
- Result Code (Positive, Doubt, Negative, Not available)
- Number of received and analysed images
- List of anomalies
- The “Result Images”: a copy of each original analysed image with additional information from BoneView.
- On each image analyzed by BoneView, an area of interest (a suspicion of an anomaly) can be signalled in 2 different ways:
- Solid line box when the probability of an anomaly is high on this area of interest. It is equivalent to POSITIVE.
- Dotted line box when there is a doubt on the presence of an anomaly in the area of interest. It is equivalent to DOUBT and the user is encouraged to carefully inspect the area.
- The total number of areas of interest detected by BoneView on the image (sum of POSITIVE and DOUBT areas) will be reminded in the lower-right corner of the image.
EU risk class and CE marking
BoneView has CE marking (CE2797) and EU MDR class IIa
Reimbursement status
Not reimbursed
Contraindications
- BoneView is not intended to be used for X-ray radiographs from the skull and cervical spine regions.
- BoneView is not intended to be used on other exam modalities than X-rays.
- BoneView is not intended to be used on lossy exams.
Target Population
- The intended patients are persons admitted to a hospital/health institution for X-rays examination: while patients don't directly interact with BoneView, the results from the X-ray radiograph they just underwent are processed via BoneView and will be used by the clinicians in their diagnosis.
Limitations
- BoneView/ChestView only provides preliminary data, the final diagnosis shall rely upon the physician’s expertise.
- BoneView/ChestView is intended for use as a concurrent reading aid during the interpretations of radiographs.
- Particular attention needs to be provided to the exam where:
- Bone View/ChestView has not received or analyzed all the images
- BoneView/ChestView did not provide results on all the image
- The results from BoneView/ChestView are different images from the original images
- In the case of an update of the PACS or RIS solution, Gleamer shall be contacted to ensure the continued compatibility of BoneView with the updated software
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