(24 days)
15-inch (38cm) Color LCD Monitor CDL1566A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
CDL1566A is a 15-inch high definition color medical imaging LCD monitor with high luminance (350cd/m² (typ.)) and high contrast screen (700:1 contrast ratio). Color LCD Monitor CDL1566A is to be used with FUJINON endoscope system, and is manufactured exclusive for FUJINON.
I am sorry, but the provided text describes a 510(k) summary for a medical display monitor (TOTOKU ELECTRIC CO., LTD. 15-inch (38cm) Color LCD Monitor CDL1566A), not an AI device.
Therefore, it does not contain information about:
- Acceptance criteria and reported device performance related to an algorithm's diagnostic accuracy.
- Sample sizes for test or training sets, data provenance, or the number/qualifications of experts.
- Adjudication methods, MRMC studies, standalone algorithm performance, or types of ground truth for an AI model.
The document focuses on the device's technical specifications (luminance, contrast, size), its intended use as a display for medical images (excluding mammography), and its substantial equivalence to a predicate device based on hardware characteristics.
§ 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).