| K-number | K243307 |
| Device name | LCD Monitor (MDEC-2523) |
| Applicant | Barco N.V. |
| Product code | GCJ |
| Device class | Class II |
| Decision date | Dec 13, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The MDEC-2523 is a medical-grade LCD monitor with a 23.8-inch color display intended to show real-time medical images from endoscopic or laparoscopic camera systems during surgical procedures. It is designed for use in hospital operating rooms, surgical centers, doctor's offices, clinics, and similar medical environments.
The device uses identical principles of operation and fundamental technology to the predicate device (4K UHD LCD Monitor OEV321UH). Differences exist in system parameters including device dimensions, input/output signals, active screen size, resolution, timings, luminance, gamma curve, and color space. These dimensional and specification variations do not raise new safety or effectiveness concerns.
Electrical safety testing per ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012; EMC testing per IEC 60601-1-2 Edition 4.1 2020-09; environmental testing including climate, shock, vibration, and thermal analysis; and software testing.
The device shares identical operating principles and fundamental technology with the predicate device. Although specific parameters differ (dimensions, resolution, brightness, color space), electrical safety and EMC test results demonstrate equivalent performance with no new concerns. The variations in specifications are design-level differences that do not fundamentally alter the device's safety or effectiveness profile.
View the full FDA submission: accessdata.fda.gov