(43 days)
The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.
PHILIPS Inturis Cardio Image Viewing Package is software that can be loaded on a workstation which has a Windows NT (4.0) Operating System. The Inturis Cardio Image Viewing workstation provides for viewing and analysis of DICOM Cardiac images which are transported to the workstation via CD-Rom. Quantitative Coronary and Left Ventricular analysis may be performed on these images.
The provided text is a 510(k) premarket notification for the Philips Inturis Cardio Image Viewing Package. This document outlines the intended use, system description, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications necessary to answer your request.
Therefore, I cannot extract the requested information from the provided text. The document is primarily focused on demonstrating substantial equivalence for regulatory approval, not on presenting performance study 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).