(97 days)
MultiView is a software application that is intended for use in processing, manipulating, and displaying magnetic resonance imaging (MRI) images as well as other multi-modality DICOM medical images and data that it receives from various sources (e.g. CT. US, secondary capture devices, scanners, imaging sources, and imaging gateways).
MultiView provides various image processing and measurement tools to facilitate the interpretation of breast MRI images and enable diagnosis. These computer-aided and/or userdefined processing functions include artifact minimization, image subtractions, multi-planar reformats, and maximum intensity projections. It also includes the following automatic functions: physiological analysis tools, diffusion analysis, and segmenting of lesions. MultiView also provides tools for automated targeting for breast interventional procedures.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA.
MultiView is typically used by trained professionals, including radiologists. technologists and clinicians and may provide information to be used for screening, diagnostic and interventional procedures. Patient management decisions should not be made solely on the results of MultiView analvsis.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the device "MultiView." It describes the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed acceptance criteria for the device's performance, nor does it describe the specific study that would prove the device meets these criteria.
The 510(k) clearance focuses on regulatory equivalence, not a detailed technical performance study with acceptance criteria and results. Such detailed information would typically be found in the manufacturer's 510(k) submission document itself, which is not provided here.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document states what the device is, its regulation, and the FDA's regulatory decision, but not how its performance was evaluated against specific metrics.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).