(14 days)
The GuideMia system is intended as software interface to transfer DICOM images generated by CT scanners, an image segmentation system to create dental anatomies from scan images, and a preoperative software for simulating/evaluating dental implant placement and surgical treatment options.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "GuideMia Software System". It does not contain information about the acceptance criteria and study results for the device. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given input document. If you have a different document that details the acceptance criteria and study that proves the device meets them, please provide it.
§ 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).