ClearVision DR 2000 Digital Radiography X-Ray System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101779 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ClearVision DR 2000 is a Stationary Digital Radiography X-Ray System, designed for capturing high-resolution digital radiographic images. It replaces traditional film-based techniques by converting X-ray exposure into digital signals for immediate viewing and analysis, supporting diagnostic imaging of skeletal and soft tissue structures.
This system is supplied as a complete unit, including a tube head/collimator assembly mounted on a U-Arm, an X-ray generator, generator control, and a digital detector. It is intended for use in radiology departments, is non-sterile, and is classified as a reusable medical device under FDA 510(k) and MDR regulations. The system operates in non-MRI environments and is available in a single configuration as specified by the manufacturer.
Frequently asked questions
What types of imaging can the ClearVision DR 2000 perform, and why is it considered an upgrade from traditional methods?
The ClearVision DR 2000 is designed for capturing high-resolution digital radiographic images of both skeletal and soft tissue structures. Unlike traditional film-based X-ray systems, it converts X-ray exposure directly into digital signals, enabling immediate viewing and analysis on a computer. This eliminates the need for chemical processing, reduces patient exposure time, and provides faster, more accessible diagnostic results for radiologists.
Is the ClearVision DR 2000 system reusable, and what does that mean for maintenance and cleaning?
Yes, the ClearVision DR 2000 is classified as a reusable medical device. This means it is intended for repeated use across multiple patients, requiring proper cleaning, disinfection, and maintenance between procedures to ensure safety and functionality. The manufacturer’s instructions should be followed to avoid cross-contamination and to preserve the system’s performance.
How is the ClearVision DR 2000 system supplied, and does it include all necessary components for immediate use?
The ClearVision DR 2000 is supplied as a complete, standalone unit, including a tube head/collimator assembly mounted on a U-Arm, an X-ray generator, generator control, and a digital detector. No additional components are required for basic operation, making it ready for immediate use in radiology departments after installation and setup.
What regulatory pathways has the ClearVision DR 2000 followed, and how does that affect its availability?
The ClearVision DR 2000 has undergone FDA 510(k) clearance and EU MDR (Medical Device Regulation) authorization, confirming its compliance with U.S. and European safety and performance standards. This regulatory approval ensures its availability for use in radiology departments within those regions, adhering to strict quality and safety requirements.
Can the ClearVision DR 2000 be used in environments where MRI machines are present, and why?
No, the ClearVision DR 2000 is explicitly designed for use in non-MRI environments. X-ray systems like this one generate electromagnetic interference that could disrupt MRI functionality, and MRI environments require strict electromagnetic shielding to protect sensitive imaging equipment. Always ensure proper separation from MRI suites.
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: CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM by JPI HEALTHCARE ..., PDF JPI ClearVision2000 - awalshimaging.net, Clearvision Dr 2000 Digital Radiography X-ray System, CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM by JPI HEALTHCARE ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101779 | Class II | Active |
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Manufacturer
- Manufacturer
- Jpi Healthcare. Co., Ltd.
- FDA Applicant
- Jpi Healthcare Co, Ltd.
Sources (2)
- FDA 510(k) K101779 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026