JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
by Nanjing Jusha Display Technology Co., Ltd.
510(k) K183497
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183497 | Date15 Jan 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- PGY
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Jusha M260G LCD Monitor is a diagnostic radiology display designed for medical imaging applications. Classified as a Display, Diagnostic Radiology device, it provides high-resolution visual output essential for accurate interpretation of radiographic images. Its monochrome design and 2MP resolution support detailed imaging analysis, adhering to DICOM standards for consistency in clinical environments.
This monitor is supplied as a reusable device intended for use in radiology settings, where precise image quality is critical. With a 21.3-inch display, it offers a resolution of 1600 x 1200 pixels, a maximum brightness of 1000 cd/m², and a contrast ratio of 1400:1. Built-in sensors automatically adjust brightness in real time to optimize visibility. Regulated under FDA 510(k) clearance (K183497), it complies with regulatory standards for diagnostic imaging displays.
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Questions
AI-generated answers, 1 Oct 2026
What is the Jusha M260G LCD Monitor designed for?
The Jusha M260G LCD Monitor is specifically designed for diagnostic radiology applications. Its high-resolution (1600 x 1200 pixels) monochrome display ensures accurate visualization of radiographic images, adhering to DICOM standards. This makes it ideal for clinical environments where precise image interpretation is critical, such as radiology departments.
Is the Jusha M260G LCD Monitor single-use or reusable?
The Jusha M260G LCD Monitor is a reusable device. It is intended for repeated use in radiology settings, where consistent image quality and durability are essential. Reusability aligns with clinical workflows that require reliable, long-term performance without the need for frequent replacements.
What display specifications does the Jusha M260G LCD Monitor offer?
The Jusha M260G LCD Monitor features a 21.3-inch display with a resolution of 1600 x 1200 pixels, providing sharp and detailed visual output. It achieves a maximum brightness of 1000 cd/m² and a contrast ratio of 1400:1, ensuring clear visibility of radiographic images. Additionally, built-in sensors automatically adjust brightness in real time to optimize viewing conditions.
How is the Jusha M260G LCD Monitor regulated?
The Jusha M260G LCD Monitor has received FDA 510(k) clearance under the reference number K183497. This clearance confirms that the device meets regulatory standards for diagnostic radiology displays, ensuring its safety and effectiveness for use in clinical settings. The device is classified under the product code PGY and falls under the Radiology advisory committee.
What are the key features that make this monitor suitable for radiology?
The monitor’s suitability for radiology stems from its monochrome design, which reduces eye strain during prolonged use, and its high-resolution (2MP) display, which ensures fine details in radiographic images are visible. The auto-adjusting brightness feature minimizes glare and adapts to varying lighting conditions, while the DICOM compliance guarantees consistency with clinical imaging systems. These features collectively enhance diagnostic accuracy and workflow efficiency.