(23 days)
RadiForce GX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
RadiForce GX320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GX320 displays high-definition medical imaging.
No information is available regarding acceptance criteria or a study that proves the device meets acceptance criteria in the provided text. The document is a 510(k) summary for a medical display monitor, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and a study to prove they are met.
§ 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).