8MP Color LCD Monitor C81W+

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K162527

by Shenzhen Beacon Display Technology Co., Ltd.

Identifiers

510(k) Number: K162527 FDA 510(k)
FDA Product Code: PGY FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.2050 FDA 510(k)
Regulation Number: 892.2050 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The 8MP Color LCD Monitor C81W+ is a diagnostic display designed for radiology applications, classified as a Class II medical device under FDA regulations. It provides high-resolution imaging with a native resolution of 4096×2160 pixels, enabling precise visualization of medical images for diagnostic purposes.

This monitor is supplied as a reusable device and is intended for use in radiology settings, where stable image quality is critical. It features an LED backlight and integrated ambient light sensors to maintain consistent brightness and calibration. The device has received FDA 510(k) clearance under K-number K162527 and complies with MDR requirements, ensuring regulatory compliance for diagnostic imaging applications.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 8MP Color LCD Monitor (C81W+) (K162527) — FDA 510(k) | Innolitics, Shenzhen Beacon Display 8MP Color LCD Monitor (c81w+), 8MP Color LCD Monitor (C81W+) 510 (k) K162527 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K162527	Class II	Active

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Manufacturer

Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.

Sources (2)

FDA 510(k) K162527 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced Jun 5, 2026