LCD Monitor (CL1902A, CL2103F)

The CL1902A and CL2103F are LCD monitors designed to display radiological images for review, analysis, and diagnosis by trained medical practitioners. The CL1902A is a 19-inch 1.3MP monitor with 1280x1024 resolution, while the CL2103F is a 21.3-inch 2MP monitor with 1600x1200 resolution. Both feature LED backlighting, brightness stabilization, anti-glare screens, and DICOM Part 3.14 calibration. Neither device is intended for mammography.

CL1902A uses an IPS panel versus the predicate's VA panel, includes BNC inputs not in the predicate, features different power specifications (<50W vs <28W), and lacks the predicate's ambient light sensor. CL2103F has similar IPS panel technology to its predicate but differs in aspect ratio orientation (4:3 vs 3:4), input/output interfaces, power consumption (<50W vs <54W), and luminance calibration approach. Both devices show minor variations in scanning frequencies and video bandwidth but maintain equivalent pixel pitch to their respective predicates.

DICOM Part 3.14 for display calibration, AAPM Task Group 18 (TG18) guideline for display performance assessment, and FDA Guidance for Display Devices for Diagnostic Radiology. Testing included spatial resolution measurement, pixel defect analysis, temporal response, luminance verification, DICOM GSDF conformance, and color tracking assessment.

The devices are substantially equivalent because they have identical intended uses (displaying radiological images for diagnosis by trained practitioners), demonstrated equivalent display characteristics through bench testing, and their technological differences do not impact safety or effectiveness or introduce new risks. The comparison tables show that despite design variations in panel technology, interfaces, and power specifications, both devices maintain the same fundamental performance metrics and meet the same calibration standards as their predicates.