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510(k) Data Aggregation
K Number
K241490Device Name
Contour+ (MVision AI Segmentation)
Manufacturer
MVision AI Oy
Date Cleared
2024-10-18
(147 days)
Product Code
QKB
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MVision AI Oy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Contour+ (MVision Al Segmentation) is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT and MR images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows.
The system creates initial contours of pre-defined structures of common anatomical sites, i.e., Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis.
Contour+ (MVision Al Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
Device Description
Contour+ (MVision Al Segmentation) is a software-only medical device (software system) that can be used to accelerate region of interest (ROI) delineation in radiotherapy treatment planning by automatic contouring of predefined ROIs and the creation of segmentation templates on CT and MR images.
The Contour+ (MVision Al Segmentation) software system is integrated with a customer IT network and configured to receive DICOM CT and MR images, e.g., from a CT or MRI scanner or a treatment planning system (TPS). Automatic contouring of predefined ROIs is performed by pre-trained, locked, and static models that are based on machine learning using deep artificial neural networks. The models have been trained on several anatomical sites, including the brain, head and neck, bones, breast, lung and abdomen, male pelvis, and female pelvis using hundreds of scans from a diverse patient population. The user does not have to provide any contouring atlases. The resulting segmentation structure set is connected to the original DICOM images and can be transferred to an image visualization system (e.g., a TPS) as an initial template for a medical professional to visualize, modify and approve prior to further use in clinical workflows.
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K Number
K212915Device Name
MVision AI Segmentation
Manufacturer
MVision AI
Date Cleared
2022-05-03
(232 days)
Product Code
QKB
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MVision AI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MVision AI Segmentation is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows.
The system creates initial contours of pre-defined structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis in adult patients.
MVision AI Segmentation is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
Device Description
MVision AI Segmentation is a software only medical device which can be used to accelerate region of interest (ROI) delineation in radiotherapy treatment planning by creating automatic segmentation templates on CT images for these ROIs.
The segmentations are produced by pre-trained, locked, and static models that are based on deep artificial neural networks. The produced structure is intended to be used as a template for medical professionals to visualize, modify and approve prior to further use in clinical workflows.
The system is integrated with the customer IT network to receive DICOM images. CT images from, for example, a scanner or a treatment planning system (TPS) are exported to the device. A structure set is created in the device, and the created segmentation results are connected to the original images. These data are sent to the destination DICOM import folder to import the data to, for example, a treatment planning system. The produced structures can then be used as a template for manual ROI editing, review and approval workflow. The segmentations are produced by pre-trained and locked models that are based on deep artificial neural networks. To take the device into use, the user does not have to provide any contouring atlases. The models have been trained with the order of hundreds of scans, depending on the ROI in question. The MVision AI Segmentation device creates initial contours of pre-defined structures of common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis.
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