(28 days)
The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the SmartSpot 2000 Image Processing System. This document does not contain information about acceptance criteria, study details, or performance metrics for the device.
Therefore, I cannot provide the requested information. The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices, allowing its marketing. It does not elaborate on the specific studies or data that led to this determination, nor does it define acceptance criteria for the device's performance.
§ 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).