Product info
- Product name:64 Slice 32 Rows CT Xray Scanner
- Product code:CCXCT6
Packaging Specifications
- Outer Packaging Size:4 × 4 × 1.7 m
- Gross Weight:1000 kg
- Net Weight:0 kg
- Volume:27.2
Description
64 Slice 32 Rows CT Scanner - Product Description
1. Product Introduction
The 64 Slice 32 Rows CT Scanner is a professional medical X-ray device. Integrating advanced biomedical engineering technologies and extensive clinical experience, it is manufactured in strict compliance with international medical device standards and relevant regulations.
This equipment operates stably in complex and demanding clinical environments. Adopting cutting-edge technologies and ergonomic design, it is easy to use for qualified professional medical staff. It is widely applied in hospitals, clinics, diagnostic centers, imaging departments and medical research institutions worldwide. Developed through extensive research and clinical trials, it ensures patient safety, accurate diagnosis and reliable operation. Every unit has passed strict quality inspections and meets or exceeds international regulatory and quality standards.
2. Main Product Features
- Equipped with advanced tube technology and high-frequency X-ray generation system
- Supports digital imaging and real-time image display
- Complete patient safety functions with optimized radiation dose
- Built with advanced radiation protection systems and shielding structures
- Adopts noise reduction algorithms to improve overall image quality
- Multi-mode operation to satisfy various clinical examination requirements
3. Detailed Technical Parameters
表格
| Parameter | Specification |
|---|---|
| Product Name | 64 Slice 32 Rows CT Scanner |
| Product Type | Medical X-ray Equipment |
| Power Output | 64 kW |
| Current Output | 32 mA |
| Voltage Output | 125 kV |
| Quality Standard | International Medical Device Standards (ISO 13485, ISO 10993) |
| Certifications | FDA Approved, CE Marked, ISO 13485 Certified |
| Sterilization Method | Ethylene Oxide (EO) Sterilization or equivalent method |
| Sterility Assurance Level | 10⁻⁶ (Compliant with ISO 11135) |
| Shelf Life | 5 years from the sterilization date under proper storage conditions |
| Storage Conditions | Room temperature (15-25°C), dry environment, keep away from direct sunlight |
4. Clinical Applications
Intended Use: This device shall only be operated by trained and qualified medical personnel in formal medical institutions. All operations must follow medical device regulations and clinical guidelines for diagnostic and therapeutic work.
- Radiography: Routine radiographic examinations
- Fluoroscopy: Real-time dynamic imaging for interventional procedures
- Diagnostic Imaging: Clinical examination and patient assessment
- Orthopedic Imaging: Imaging examination of bones and joints
- Thoracic Imaging: Examination of chest and respiratory system
5. Product Advantages
- Superior image quality and outstanding diagnostic performance
- Stable and consistent operation
- Intuitive interface and simple operation
- Fully compliant with safety regulations with complete certifications
- Professional technical support and comprehensive supporting services
- Robust structure for long service life
- Fully compliant with international medical device standards
6. Regulatory Compliance & International Certifications
This device meets all international regulatory requirements and holds the following authoritative certifications:
- FDA Approval: Authorized for sales and clinical use in the United States
- CE Marking: Compliant with EU Medical Device Regulations, available for circulation and use across the European Union
- ISO 13485: Manufactured under certified quality management system for stable product quality
- ISO 10993: Compliant with biocompatibility standards for medical devices
- ISO 11135: Ethylene oxide sterilization process conforms to relevant standards
- General International Standards: Compliant with all applicable international medical device regulations and specifications
7. Usage Guidelines & Precautions
- Personnel Requirements: Operators must receive professional training and hold valid qualifications, and abide by relevant regulations and manufacturer’s instructions
- Safety Rules: Strictly follow safety codes and operating procedures stated in product manuals and training documents
- Maintenance & Calibration: Perform regular maintenance and calibration to maintain equipment performance, accuracy and extend service life
- Quality Control: Use the equipment in accordance with medical device regulations, quality standards and internal institutional rules
- Technical Support: Professional team provides assistance, troubleshooting and operational training
- Documentation Management: Properly retain records of usage and maintenance to meet compliance and quality control requirements
8. Quality Assurance & Performance Standards
Every CT scanner undergoes rigorous testing and verification covering the following items:
- Functional and accuracy tests under clinical working conditions
- Effectiveness inspection of safety protection devices
- Durability and long-term reliability tests for clinical use
- Verification of regulatory compliance and relevant certifications
- Practicality and usability tests of the operating interface
- Inspection of image quality and diagnostic accuracy
9. Supporting Services
We provide a full range of supporting services to ensure stable equipment operation:
- Technical Support: 24/7 technical consultation and troubleshooting
- Training Service: Complete professional training for operators and medical staff
- Maintenance Service: Customized preventive maintenance plans to keep the equipment in optimal condition
- Spare Parts Supply: Genuine original components and matching accessories
- Regulatory Assistance: Guidance on regulatory compliance and document arrangement
- Clinical Consultation: Professional clinical advice to maximize equipment application value
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