(126 days)
This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
RadiForce RX270 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
There are two model variations. RX270 and RX270-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX270 is Anti-Glare (AG) treatment and that of the RX270-AR is Anti-Reflection (AR) coating.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX270 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX270.
RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce RX270 and it's not a medical imaging software.
This document does not contain information about an AI/ML device or its performance criteria. The device described, RadiForce RX270 and RX270-AR, is a medical grade display monitor. The submission states that the device is "indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography."
The performance testing section (Section 7) describes bench tests performed on the display monitor to evaluate its characteristics, such as spatial resolution (MTF), pixel defects, artifacts, temporal response, luminance, and conformance to DICOM GSDF. These tests are standard for evaluating medical displays and ensure the monitor can accurately present radiological images.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, a multi-reader multi-case (MRMC) study, or standalone algorithm performance. The document focuses on the technical specifications and performance validation of a display device, not an AI or imaging analysis product.
§ 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).