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JUSHA-C33C LCD Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141684

by Nanjing Jusha Display Technology Co., Ltd.

Identifiers

510(k) Number
K141684 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-C33C LCD Monitor is a diagnostic radiology display device designed for viewing digital medical images. It is intended for use by trained medical practitioners to display images for the diagnosis of X-ray or MRI scans.

This device is regulated under FDA 510(k) clearance number K141684. It is not intended for the display of mammography images for diagnosis.

Frequently asked questions

What is the intended use of the Jusha-C33C LCD Monitor?

This device is designed for use by trained medical practitioners to display digital medical images for the diagnosis of X-ray or MRI scans.

Can this monitor be used for mammography diagnosis?

No, the Jusha-C33C LCD Monitor is not intended for the display of mammography images for diagnosis.

What is the regulatory status of this device?

The Jusha-C33C LCD Monitor is regulated under FDA 510(k) clearance number K141684, which indicates it has been found substantially equivalent to other legally marketed devices.

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-C33C LCD MONITOR by NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD ..., JUSHA-C33C LCD MONITOR (K141684) — FDA 510 (k) | Innolitics, Nanjing Jusha Display Technology Co., Ltd., K141684 FDA 510 (k) - JUSHA-C33C LCD MONITOR, JUSHA-C33C LCD MONITOR by NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K141684 24 fields · synced Sep 22, 2026