ASUS MH Series Clinical Displays Listed as Class 1 Devices by US FDA

Monitors meet the DICOM Part 14 Grayscale Standard Display Function AAPM TG270 standard and deliver consistent and highly accurate medical imagery

• ASUS MH series clinical displays now listed as Class 1 Devices by the US Food and Drug Administration (FDA)
• FDA-certified displays include the 32" 8 MP MH3281A, 27" 4 MP MH2741A, and the 23.8" MH2441A
• Compliant with the DICOM Part 14 GSDF standard; displays include a built-in colorimeter with auto-calibration feature to ensure accuracy

TAIPEI, Taiwan, February 26, 2024 — ASUS today announced that the latest ASUS MH series clinical displays have been listed as Class 1 Devices by the US Food and Drug Administration (FDA). These models include the 32-inch 8-megapixel MH3281A, the 27-inch 4-megapixel MH2741A, and the 23.8-inch MH2441A. All three displays are designed for radiology, as well as Picture Archiving and Communication System (PACS) use.

 All three monitors meet the DICOM Part 14 Grayscale Standard Display Function (GSDF) AAPM TG270 standard, and each includes a scheduled calibration feature, dynamic brightness compensation, and dynamic DICOM compensation to ensure consistent and highly accurate medical images. The monitors feature an anti-glare, low-reflection (AGLR) coating on the panel, and have undergone stringent performance tests. They have been certified by TÜV Rheinland to ensure flicker-free performance and low blue light emissions. These clinical displays also meet ISO 13485 requirements, and are certified for use in clinics and large medical institutions.

In addition to FDA certification, ASUS is seeking CE marks indicating compliance with EU Medical Device Regulation guidelines as well as approval from the Taiwan Food and Drug Administration (TFDA) for its clinical displays. Aiming to provide a range of new solutions for European and Asia markets, ASUS is also actively pursuing partnerships with major medical institutions across the globe, seeking to better understand industry needs and to respond to ever-changing medical-device market.