JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
by Nanjing Jusha Display Technology Co., Ltd.
510(k) K183496
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK183496 | Date8 Apr 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The Jusha-C350G LCD Monitor is a diagnostic display device designed for use in radiology settings. It provides high-resolution visual output for interpreting medical imaging studies, including X-rays, CT scans, and other diagnostic modalities, ensuring accurate assessment by radiologists and healthcare professionals.
This monitor is supplied as a reusable, non-sterile device intended for clinical environments where diagnostic imaging is performed. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The device is intended for use in radiology departments and adheres to safety standards for diagnostic imaging displays.
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Questions
AI-generated answers, 18 Sep 2026
Is this monitor intended for single-use or can it be reused in a clinical setting?
The Jusha-C350G LCD Monitor is designed as a reusable device for clinical environments, specifically radiology departments. It is explicitly labeled as non-sterile and intended for repeated use in diagnostic imaging workflows.
What types of medical imaging studies is this monitor optimized for, and why is that important?
This monitor is optimized for interpreting high-resolution medical imaging studies like X-rays, CT scans, and other radiology modalities. Its design ensures accurate visual output, which is critical for radiologists and healthcare professionals to make precise diagnostic assessments.
How is the Jusha-C350G LCD Monitor regulated, and what does that mean for its use in a hospital?
The monitor holds FDA 510(k) clearance and MDR authorization, classifying it as a Class II medical device under FDA regulations. This means it has undergone evaluation for safety and performance, ensuring it meets standards for use in radiology departments as a diagnostic display device.
Are there different sizes or models available for this monitor, and if so, how would I identify them?
The device is marketed under multiple names—JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, and C350 LCD Monitor—but no specific size variations are detailed in the provided data. The naming conventions may indicate minor model distinctions, but all appear to serve the same core purpose for radiology imaging.