8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
Shenzhen Beacon Display Technology Co., Ltd.The 8MP Color LCD Displays (models C811W, C811WT, PA27, PA27T) are high-resolution color LCD screens designed to display digital images of histopathology slides for primary diagnosis. They aid pathologists by providing stable, calibrated, and precise image visualization from validated whole-slide imaging systems, assisting in the interpretation of digital pathology images.
Intended Use
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Technology
The device comprises 27-inch 8MP color LCD panels with LED backlight and fine pixel pitch. It uses advanced color calibration (sRGB), brightness stabilization, and a front sensor calibration feedback system to ensure consistent high precision image display. Some models include capacitive touch screens. The displays are optimized for viewing digital pathology images from validated IVD whole-slide imaging systems, providing accurate and stable color and luminance performance.
Performance
Performance testing showed the displays meet or exceed standards for user controls, spatial resolution, pixel defects, artifacts, temporal response, luminance, grayscale, uniformity, stability with temperature and lifetime, reflectance, gray tracking, color scale, and color gamut volume. These tests demonstrate equivalence or better performance compared to a predicate device. No clinical or animal testing was needed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2023
1 year, 3 months - 2
FDA Approval
12/28/2024
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