(35 days)
19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus) 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.
CDL1902A (CCL192 plus) is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.
The provided text does not contain information about acceptance criteria, device performance, or any studies proving device performance. The document is a 510(k) summary for a medical monitor, primarily focusing on its substantial equivalence to a predicate device and its intended use. It describes the device, clarifies its classification, and lists the contact information for the submitter. There is no mention of any clinical or performance studies, sample sizes, expert involvement, or ground truth establishment.
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).