(85 days)
The ImageDesk device is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The ImageDesk device is a digital image display system. The ImageDesk device is a system consisting of components to provide high resolution visualization of digital images.
No specific acceptance criteria or details of a study proving the device meets acceptance criteria are provided in the given text.
The document is a 510(k) summary and FDA clearance letter for a medical imaging display system. It describes the device, its intended use, and confirms substantial equivalence to a predicate device. However, it does not include information about performance studies, acceptance criteria, or specific metrics like accuracy, sensitivity, or specificity that would typically be found in a study proving device performance.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and study details based on the provided text.
§ 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).