(43 days)
21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
MDL2109A (ME251i) (DV2MM-HB) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.
The provided document is a 510(k) summary and FDA approval letter for a monochrome LCD monitor. It does not contain information about acceptance criteria and a study proving the device meets those criteria. The document focuses on establishing substantial equivalence to a predicate device and its intended use.
Therefore, I cannot provide the requested 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).