(311 days)
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optional package: CT/MR MATCHING
This document is a 510(k) summary for Philips Medical Systems' "CT/MR MATCHING for use in PHILIPS EasyVision CT/MR workstations." It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device meets such criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily makes high-level claims about safety and effectiveness based on past experience and user information, rather than detailing a specific performance study with acceptance criteria and results.
§ 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).