(85 days)
The PHILIPS Inturis DICOM Recorder is intended for use in recording cardio-vascular images produced in the examination room (from the INTEGRIS systems, Easy Vision 4.3 onwards, or 3D workstation), on a CD-R.
PHILIPS Inturis DICOM Recorder is software that can be loaded on a Personal Computer or workstation with a Windows NT (4.0) Operating System.
The provided text is a 510(k) summary for the Philips Inturis DICOM Recorder. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria, detailed performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
Therefore, I cannot provide the requested information from the given text. The document is primarily focused on regulatory submission and demonstrating substantial equivalence rather than reporting on technical performance studies with specific statistical metrics.
§ 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).