LCD Monitors C310S, G310S, C316S, G316S, C616W
Shenzhen Beacon Display Technology Co.,Ltd.The LCD Monitors C310S, G310S, C316S, G316S, and C616W by Shenzhen Beacon Display Technology Co.,Ltd. are high-resolution, calibrated diagnostic displays specifically designed for radiology. These monitors support the viewing and analysis of digital images such as X-rays and MRIs, helping clinicians review and diagnose patient conditions accurately. They incorporate advanced LED backlighting, brightness stabilization, and anti-glare screens to ensure image clarity and consistency, crucial for precise medical evaluation.
Intended Use
LCD Monitors C310S, C316S and C616W are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography. G310S and G316S are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI by trained medical practitioners.
Technology
The devices are high-definition TFT LCD monitors with LED backlight panels calibrated to meet DICOM Part 3.14 standards. The 3MP monitors support resolution 1536 x 2048 and 6MP monitor supports 3280 x 2080 resolution. They incorporate brightness stabilization, anti-glare screens, calibrated color or monochrome panels, and USB connectivity. The calibration feedback system has been validated according to IEC 62304.
Performance
Non-clinical performance testing included software validation, cybersecurity assessment, and physical laboratory testing per FDA guidelines for diagnostic display devices. Tests confirmed compliance with DICOM GSDF, spatial resolution, pixel defects, artifacts, temporal response, luminance, grayscale-to-luminance function, and color gamut, all passing successfully. There were no animal or clinical tests required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
28 days - 2
FDA Approval
10/25/2024
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