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JUSHA-C23C LCD Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151861

by Nanjing Jusha Display Technology Co., Ltd.

Identifiers

510(k) Number
K151861 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 Jusha-C23C LCD Monitor is a diagnostic radiology display device designed for high-resolution imaging. It is classified as a Display, Diagnostic Radiology device and is intended for visualising digital medical images, including X-ray and MRI scans, in clinical settings. The monitor provides clear, accurate visualisation essential for diagnostic assessment by trained medical practitioners.

This device is supplied as a reusable, non-sterile medical display and is intended for use in radiology departments or imaging suites. It features a 2MP LED backlight with high brightness and resolution, ensuring optimal image quality for diagnostic purposes. The monitor adheres to FDA 510(k) clearance (K151861) under regulation number 892.2050 and is classified as a Class II device. Storage and handling should follow manufacturer guidelines to maintain performance and image fidelity.

Frequently asked questions

What types of medical images can the Jusha-C23C LCD Monitor display, and why is high resolution important for these images?

The Jusha-C23C LCD Monitor is specifically designed to visualize digital medical images, including X-ray and MRI scans, in clinical settings. High resolution is critical because diagnostic accuracy relies on clear visualization of fine details—such as bone structures in X-rays or soft-tissue contrasts in MRIs—to ensure radiologists or clinicians can make precise assessments without ambiguity.

Is the Jusha-C23C LCD Monitor intended for single-use or reusable applications, and what does this mean for maintenance?

The Jusha-C23C is reusable, meaning it is built for long-term use in radiology departments or imaging suites. Since it is non-sterile, maintenance involves regular cleaning and calibration per the manufacturer’s guidelines to preserve image fidelity and performance over time, rather than disposal after a single use.

What regulatory pathway was followed for FDA clearance of this monitor, and what does ‘Class II’ classification imply about its oversight?

The Jusha-C23C LCD Monitor received FDA 510(k) clearance (K151861) under the traditional pathway, classified as Substantially Equivalent to a predicate device. As a Class II device, it is subject to special controls (e.g., performance standards, labeling requirements) but does not require pre-market approval (PMA), meaning it undergoes rigorous review for safety and effectiveness without the highest scrutiny of Class III devices.

How does the LED backlight technology in this monitor contribute to its diagnostic performance?

The monitor features a 2MP LED backlight with high brightness and resolution, which enhances contrast, color accuracy, and clarity of medical images. This technology reduces eye strain for clinicians during long viewing sessions and ensures that subtle details—such as microfractures or lesions—are distinguishable, directly supporting diagnostic confidence in radiology workflows.

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: (JUSHA-C23C) 2MP LED High Resolution Monitors - China Medical Display ..., (JUSHA-C23C) 2MP LED High Brightness Monitors - China Medical Display ..., JUSHA-C23C LCD Monitor (K151861) — FDA 510 (k) | Innolitics, Nanjing Jusha Display C23C LCD Monitor - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanjing Jusha Display Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K151861 24 fields · synced Sep 19, 2026