(14 days)
ILUMA VISION is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, or 3D Ultrasound. It is intended for use by radiologist, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis and distribute DICOM 3.0 compliant images, utilizing standard PC hardware. Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments. The device is not intended for use with mammography.
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I am sorry, but the provided text does not contain information regarding objective acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA, confirming that the device, ILUMA Vision v2.0, is substantially equivalent to a legally marketed predicate device.
The letter mentions the device's intended use and the regulatory classification but does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any studies.
- Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
- Data on standalone algorithm performance.
§ 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).