(65 days)
FilmSaver NT Version 5.03 software is intended to reduce the total film consumption of a CT scanner, MRI, etc. by reducing the area needed for the diagnostic image. The device uses propriety software algorithms to receive, process, and send analog or digital radiological images. The FilmSaver product is designed to interface with industry standard radiology equipment.
FilmSaver NT Version 5.03 software
The provided document is a 510(k) clearance letter from the FDA for a device named "FilmSaver NT Version 5.03 FilmSaver Software." It does not contain any information regarding acceptance criteria, study details, or performance results of the device.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to. The "Indications for Use Statement" describes the intended purpose of the software, which is to reduce film consumption by reducing the area needed for diagnostic images from CT, MRI, etc., using proprietary software algorithms to receive, process, and send radiological images and interface with standard radiology equipment.
Therefore, I cannot provide the requested information as it is not present in the given text.
§ 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).