(28 days)
RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc. The product is not intended for use with a digital mammography system.
Color LCD Monitor, RadiForce R12
This document is an FDA 510(k) clearance letter for a medical device: an Eizo Nanao Corporation Color LCD Monitor, RadiForce R12.
Based on the provided text, there is NO information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
This letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not contain the detailed technical or clinical study data that would typically define acceptance criteria or describe a study's methodology and results.
The "Indications for Use" section (Page 2) states: "RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc. The product is not intended for use with a digital mammography system." This specifies the intended clinical application but does not provide performance metrics or acceptance criteria.
§ 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).