(55 days)
The CVIEW™ is a high performance, digital, cardiac image viewer. The System supports DICOM 3.x and higher cardiac and angio images and displays them in their original dynamic mode. The CVIEW accepts images from DICOM 3.x CDs or can be configured to read DICOM 3 images from a DICOM Archive Server. The CVIEW allows immediate playback of images from any patient stored on the system and burning CDs in the DICOM part 10 - file format.
It represents the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.
Cardio Vascular Information Enhanced Workstation™ (CVIEW)™ is a viewing stations for Cath, Echo and Angio case studies, represent the next generation in network cardiac review systems. Features include 1024 viewing, security, report generation, multi-modality viewing, databasing as well as instant access to hundreds of cases on-line or thousands through the network.
This 510(k) summary explicitly states that clinical performance data was "Not required for determination of substantial equivalence for this type and class of device." Therefore, there is no study provided within this document that describes acceptance criteria and proves the device meets them.
The Cardio Vascular Information Enhanced Workstation (CVIEW)™ was approved based on its substantial equivalence to predicate devices, meaning its intended use and technological characteristics were similar or equivalent to already legally marketed devices.
As a result, I cannot provide the requested information for acceptance criteria and a study proving their fulfillment as this information is not present in the provided document. All the numbered points in your request relate to details of a clinical study, which was not performed for this 510(k) clearance.
§ 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).