(52 days)
The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will aid with and connect to computed radiography images acquired from a FUJI Computed Radiography system, other modalities, film digitizers and image phosphor plate scanners.
WEBRAD Computed Radiography Quality Assurance (CR/QA) Workstation
I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific criteria. The document is an FDA 510(k) clearance letter for the WEBRAD Computed Radiography Quality Assurance Workstation, indicating that the device has been found substantially equivalent to legally marketed predicate devices.
The text does not provide information on:
- A table of acceptance criteria or reported device performance.
- Sample size, data provenance, number or qualifications of experts for ground truth, or adjudication methods for a test set.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used in any study.
- Sample size for training sets or how their ground truth was established.
The document primarily states the device's clearance and its intended use, which is a web-based software product to assist with the acquisition, management, and viewing of computed radiography images.
§ 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).