(227 days)
ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.
ImageQUEST is communication system that has a database to allow Imaging Professionals to store and find their images and information. ImageQUEST can create teaching files, professional presentations and E-mail images to other professionals at remote locations and generate reports.
This document is a 510(k) clearance letter from the FDA for a device called "ImageQUEST - Communications Software." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter focuses on regulatory approval based on substantial equivalence and general controls, rather than on detailed performance metrics from a specific study.
Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document acts as an approval notice, not a performance study report.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.