(41 days)
NeuroQuant™ is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmental brain structures identified on MR images.
NeuroQuant™ Medical Image Processing Software
The provided text is a 510(k) clearance letter from the FDA for the NeuroQuant™ Medical Image Processing Software. It does not contain specific details about the acceptance criteria or a study proving the device meets those criteria. Such information is typically found in the 510(k) summary or the full submission, which is not provided here.
Therefore, I cannot extract the requested information from the given text. The document only confirms that the device has been found substantially equivalent to a predicate device and can be marketed.
§ 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).