(65 days)
Video Plus is a digital imaging acquisition and review system for the cardiac video Fras is a cigation findedigital fluoroscopy, digital fluoroscopy, digital cine, real time cannoterization no. To icatalor meterssing, image processing, quantitative coronary processing digital subtraction angiography, digital video input, linked biplane acquisition, auto injection, and histogram equalization.
This is a software upgrade for the existing Video Plus System cleared under K954159. This release encompasses some general enhancements and more integrated support for certain vendors.
This document is a 510(k) Summary for a software upgrade (Video Plus software upgrade) for an existing digital image acquisition unit, Camtronics Video Plus, cleared under K954159. The submission compares the upgraded device to a predicate device, GE Medical Systems "Advantx DLX" (K945459, K926258).
The document explicitly states:
"Performance data: Not required for determination of substantial equivalence for this class of device."
"Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be provided from this document as no such data was required or presented for this 510(k) submission. The FDA clearance was based on substantial equivalence to a predicate device, not on specific performance data against acceptance criteria.
§ 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).