(247 days)
The CT/MR Quantitative Analysis Package is intended for use where visualization and analysis of CT and MR dynamic studies, showing changes in contrast over time, are useful or necessary.
The quantitative analysis package supports the visualization and analysis of CT and MR dynamic studies which show changes in contrast over time. In a dynamic study, a time series of scans is acquired over a single or multiple slice location. The image contrast variations over time will be displayed in "Time Intensity Diagrams (TID)". These TIDs enable analysis of time dependent behavior per individual pixel, Region of Interest (ROI), or Volume of Interest (VOI). TIDs feature user definable intensity and time axes in combination with curve smoothing and curve fitting to determine modality dependent functional parameters. The functional parameters will be presented numerically and a selection of the functional parameters will be visualized as functional images. Subtraction of time series of contrast enhanced images from non-contrast enhanced images to provide the enhanced contrast only is also a function provided by the package.
The provided document, K971965, is a 510(k) Summary of Safety and Effectiveness for the "Philips Easyvision Family Workstation Option Quantitative Analysis Package". This document does not describe acceptance criteria or a study proving the device meets those criteria.
The document focuses on:
- Intended Use: Visualization and analysis of CT and MR dynamic studies showing changes in contrast over time.
- System Description: Details how the package supports visualization and analysis of dynamic studies, including "Time Intensity Diagrams (TID)", curve smoothing, curve fitting, and computation of functional parameters (e.g., maximum intensity, wash in, wash out, time to max, regional Cerebral blood flow, time to peak, mean transit time). It also mentions the creation of functional images.
- Predicate Devices: Philips Gyroview HR (K921219) and GE Advantage Windows with FuncTool Option (K960265).
- FDA Clearance Letter: Confirms substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as it is not present in 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).