(81 days)
The Data Ray Corporation DR11021 Medical Imaging Monitor is intended to be used by radiologists/trained practitioners to examine digitized x-ray images for the purpose of medical analysis.
The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.
The DR11021 Medical Imaging Monitor is a diagnostic display used in film-less radiology applications.
The Data Ray Corporation DR11021 Medical Imaging Monitor is a high resolution monitor with the electronic capability necessary for displaying high resolution medical images for the purpose of evaluation.
The provided document is a 510(k) Premarket Notification Summary for the "DR11021 Medical Imaging Monitor" by Data Ray Corporation. This document concerns a medical display monitor and does not contain any information about acceptance criteria or a study proving device performance for an AI/CADe device.
The document describes the monitor's intended use (displaying digitized X-ray images for medical analysis by radiologists/trained practitioners) and its technological characteristics (high-resolution display). It also lists substantially equivalent predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance, as the provided text does not contain this information.
§ 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).