(191 days)
3M Color Medical Flat Panel Display, CCL316, is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians. It is not meant to be used for digital mammography.
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This document is a 510(k) premarket notification approval letter for the 3M Color Medical Flat Panel Display, CCL316. It indicates that the device is substantially equivalent to a legally marketed predicate device.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the specific details requested in your prompt.
The letter solely grants permission to market the device based on a determination of substantial equivalence, and it specifies the indications for use. It does not include the detailed technical study information you've asked for.
§ 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).