(14 days)
The UroCARE1.0 is a soft-copy reading workstation intended for clinical review of CT abdominal (urology) images which allows easy acquisition, transmission and review of the medical images and supports HD ROI (High Density Region of Interest) analysis. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis, except in the case of mammography images.
UroCARE1.0 software product is a soft-copy reading workstation for clinical review of CT abdominal (urology) images. It is a self-contained software package and provides general features of 2D image display, standard Multi-Planar Reformation (MPR) views and 3D views of Volume Rendering. An additional feature, HD ROI analysis, allows for segmentation of high density regions in terms of user-defined threshold within a user-given ROI as well as display and quantitative analysis of the segmented HD ROI.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the UroCARE1.0, outlining its intended use, description, and substantial equivalence to predicate devices, but lacks the detailed performance study information requested.
Therefore, I cannot provide the tables and information requested.
§ 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).