K-numberK233119
Device name8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
ApplicantShenzhen Beacon Display Technology Co., Ltd.
Product codePZZ
Device classClass II
Decision dateDec 28, 2024
DecisionSubstantially Equivalent
Regulation864.3700
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The 8MP Color LCD Displays (models C811W, C811WT, PA27, PA27T) are medical-grade display monitors intended for in vitro diagnostic use to show digital images of histopathology slides from whole-slide imaging scanners. They aid pathologists in reviewing and interpreting digital pathology images for primary diagnosis, with capacitive touchscreen available on WT and T models.

Technological characteristics

27-inch color LCD panels with 3840x2160 resolution at 60Hz, LED backlighting, sRGB color calibration at 500 cd/m² luminance, 1000:1 contrast ratio, and multiple display interfaces (DVI-D, HDMI, DisplayPort). Key differences from predicate: AHVA panel technology vs. IPS, added capacitive touchscreen on some models, different calibration feedback system, and slightly higher luminance (500 vs. 450 cd/m²).

Test standards cited

IDMS 1.03 (Image Displays in Medical System) standard used for performance testing, including assessments of spatial resolution (MTF), pixel defects, grayscale, luminance uniformity, color scale, and color gamut volume.

Substantial equivalence argument

The proposed device shares the same intended use as the predicate (display of histopathology images for primary diagnosis) and demonstrates equivalent display performance across 13 measured parameters despite design differences. Although the displays use AHVA panel technology instead of IPS and include additional features like capacitive touchscreen, bench testing shows these differences do not affect safety or effectiveness—all performance metrics remain within clinically acceptable ranges equivalent to the predicate device.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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