(24 days)
RadiForce GS520 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with performance specified by the manufacture of the system.
RadiForce GS520 device is a digital image display. G520 displays high-definition (5 Megapixel) medical imaging.
The provided text describes a 510(k) submission for a medical monitor and contains no information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the other requested study design details. The document is primarily focused on regulatory approval based on substantial equivalence to a predicate device, rather than a performance study of a new medical device.
Therefore, I cannot provide the requested table and information based on the given text.
The closest relevant information is that the device "complies with the performance specified by the manufacturer of the system" for digital mammography applications, but what that performance is, and how it was verified, is not detailed in this document.
§ 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).