(69 days)
The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs.
This information is suitable for use in the following applications:
- Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics,
- Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
Sectra Angiography and Cardiology Package is intended to support radiologists and cardiologists in the diagnostic process to quantify findings. The device has functionality for quantitative analysis of the arteriograms (QCA and QVA) and quantitative analysis of the left ventricular angiographic images (LVA). Measurements can be applied on angiographic images.
The provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The document is a 510(k) summary for the Sectra Angiography and Cardiology Package, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or specific acceptance criteria.
The "Performance Data" section merely states: "The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0." This indicates compliance with quality management systems and communication standards, not a clinical performance study with acceptance criteria.
Therefore, I cannot populate the requested table or answer most of the questions, as the information 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).