(43 days)
Synergy ODM is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye as well as in management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks.
Synergy ODM is a software platform that collects, processes, measures, analyzes, stores, and manages patient data and clinical information. Synergy ODM is used together with a number of computerized digital imaging devices. In addition, Synergy ODM software collects and manages patient demographics, image data, and clinical reports from a range of medical devices. Synergy ODM enables a real-time review of diagnostic patient information at a PC workstation. Synergy ODM also includes an internetbrowser-based user interface to allow authorized users to access, view, create reports, and analyze patient and examination data saved in a centralized database. The system utilizes dual level authentication and 128-bit encryption to ensure secure networking environment.
The provided text for K132667 states: "No performance data was required or provided. Software validation and verification demonstrate that the Synergy ODM performs as intended and meets its' specifications."
Therefore, it is not possible to describe acceptance criteria or a study proving device performance based on the provided document. The device, Synergy ODM, is a software platform for image management in ophthalmology, and its 510(k) clearance was based on substantial equivalence to predicate devices, without requiring clinical performance data.
§ 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).