(88 days)
This device is intended to be used by all medical and dental personnel to store all patient medical or dental records on CD, Digital Audio Tapes or any future digital archivable media. The Maestro product is capable of transmitting patient records or claims to third party administrators or insurance companies for processing of patient insurance claims. Maestro allows a user to use digital zoom-in features to enlarge an x-ray film/images, or any type of document for closer examination.
Not Found
This is a 510(k) clearance letter and an intended use statement, which do not contain the detailed study information required to answer the questions about acceptance criteria and device performance. The documents confirm the device (Maestro Digital Image and Patient Record Storage System) received 510(k) clearance in 1997 for storing patient medical/dental records on digital media and transmitting them, as well as providing zoom-in features for images.
Therefore, I cannot provide the requested information based on the provided text. To answer these questions, I would need access to the actual 510(k) submission, which would include performance data, study designs, and 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).