Xray Machine Flat Panel Detector, 17x17inch - Professional Medical Device
Product Description
Xray Machine Flat Panel Detector, 17x17inch (Product Code: CCL20221020) is a professional-grade medical x-ray equipment designed for healthcare applications. This device represents advanced biomedical engineering combined with clinical expertise, manufactured to meet international medical device standards and regulatory requirements. The Xray Machine Flat Panel Detector, 17x17inch is engineered to provide reliable performance in demanding clinical environments. It combines cutting-edge technology with user-friendly design, ensuring optimal functionality for trained medical professionals. The device is suitable for use in hospitals, clinics, diagnostic centers, imaging facilities, and medical research institutions worldwide. This product has been developed through extensive research, development, and clinical testing to ensure patient safety, treatment efficacy, and operational reliability. Every unit undergoes rigorous quality control testing and meets or exceeds all international regulatory requirements and quality standards.
Key Product Features & Specifications
High-frequency X-ray generation with advanced tube technology
Digital imaging capability with real-time visualization
Comprehensive patient safety features and dose optimization
Advanced radiation protection systems and shielding
Image quality optimization with noise reduction algorithms
Multi-mode operation for various clinical applications
Detailed Technical Specifications
| Parameter | Specification |
| Product Name | Xray Machine Flat Panel Detector, 17x17inch |
| Product Code | CCL20221020 |
| Product Type | Medical X-ray Equipment |
| Power Output | 17 kW |
| Current Output | 17 mA |
| Voltage Output | 125 kV |
| Quality Standard | International Medical Device Standards (ISO 13485, ISO 10993) |
| Regulatory Certifications | FDA Approved, CE Marked, ISO 13485 Certified |
| Sterilization Method | Ethylene Oxide (EO) Sterilization or equivalent |
| Sterility Assurance Level | 10⁻⁶ (meets ISO 11135 standards) |
| Shelf Life | 5 years from sterilization date under proper storage |
| Storage Conditions | Room temperature (15-25°C), dry environment, away from direct sunlight |
Clinical Applications & Indications
Intended Use: The Xray Machine Flat Panel Detector, 17x17inch is indicated for use in professional medical environments by trained and qualified medical personnel. It is designed for diagnostic and therapeutic applications in accordance with applicable medical device regulations and clinical practice guidelines.
Radiography - General radiographic imaging procedures
Fluoroscopy - Real-time dynamic imaging for interventional procedures
Diagnostic imaging - Clinical diagnosis and patient assessment
Orthopedic imaging - Bone and joint visualization
Thoracic imaging - Chest and respiratory system examination
Product Advantages & Competitive Benefits
The Xray Machine Flat Panel Detector, 17x17inch offers significant advantages in clinical practice:
High-quality imaging and diagnostic capability
Reliable and consistent performance
User-friendly interface and operation
Safety compliance and regulatory certification
Professional technical support and services
Durable construction for long-term use
International medical device standards compliance
Regulatory Compliance & International Certifications
The Xray Machine Flat Panel Detector, 17x17inch complies with all international regulatory requirements and holds the following certifications:
FDA Approval: Approved by the U.S. Food and Drug Administration (FDA) for commercial distribution and clinical use in the United States
CE Marking: Certified under the European Medical Devices Regulation (MDR) for distribution and use throughout the European Union
ISO 13485: Manufactured under ISO 13485 certified quality management systems ensuring consistent product quality
ISO 10993: Compliant with ISO 10993 biocompatibility standards for medical devices
ISO 11135: Sterilization performed in compliance with ISO 11135 standards for ethylene oxide sterilization
International Standards: Meets all applicable international medical device standards and regulations
Usage Guidelines & Best Practices
Operator Training: Requires trained and qualified medical personnel for operation in accordance with regulatory requirements and manufacturer guidelines
Safety Protocols: Follow all safety protocols and operational guidelines provided in the comprehensive product manual and training materials
no comments