(25 days)
The InstaCine D-2000 system enables acquisition, display, electronic processing, storage and review of radiographic images generated during certain medical procedures, particularly cardiac anglographic The product is intended and radiographic/fluroscopic examinations. primarily for on-line or remore viewing of cardiac catheterization angiography studies communicated by network, or trquaporced by CD-R interchange media which have been produced in accordance with the ACC/NEMA DICOMO standard.
Not Found
The provided text is an FDA 510(k) clearance letter and an "Indications For Use" statement. It establishes the device's substantial equivalence and outlines its intended use, but it does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based solely on the input provided. The document primarily focuses on regulatory approval and the device's function rather than performance metrics or detailed 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).