Product info
- Product name:Digital Mammography System
- Product code:CC23012401
Packaging Specifications
- Outer Packaging Size:1.5 × 1.5 × 1.5 m
- Gross Weight:280 kg
- Net Weight:0 kg
- Volume:3.38
Description
Digital Mammography System - Professional Medical Device
Descripción del producto
Digital Mammography System (Código de producto: CC23012401) is a professional-grade mammography system 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 Digital Mammography System 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.
Características principales del producto & Especificacións
- Specialized breast imaging with optimized compression system
- High contrast resolution for subtle lesion detection
- Advanced compression technology for patient comfort
- Digital detection with high sensitivity and specificity
- Tomosynthesis capable for 3D breast imaging
- Automated exposure control for consistent image quality
Especificaciones técnicas detalladas
| Parámetro | Especificación |
|---|---|
| Nombre del producto | Digital Mammography System |
| Código de producto | CC23012401 |
| Tipo de producto | Mammography System |
| Estándar de calidad | International Medical Device Standards (ISO 13485, ISO 10993) |
| Certificaciones regulatorias | FDA Approved, CE Marked, ISO 13485 Certified |
| Método de esterilización | Ethylene Oxide (EO) Sterilization or equivalent |
| Nivel de garantía de esterilidad | 10⁻⁶ (meets ISO 11135 standards) |
| Vida útil | 5 years from sterilization date under proper storage |
| Condiciones de almacenamiento | Room temperature (15-25°C), dry environment, away from direct sunlight |
Aplicaciones clínicas e indicaciones & Indications
Uso previsto: The Digital Mammography System 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.
- Breast cancer screening - Population-based screening programs
- Diagnostic mammography - Symptomatic patient evaluation
- Clinical imaging - Breast tissue assessment and diagnosis
- Early detection - Detection of early-stage breast lesions
- Patient care - Comprehensive breast health management
Ventajas y beneficios competitivos del producto & Competitive Benefits
The Digital Mammography System offers significant advantages in clinical practice:
- High-quality imaging and diagnostic capability
- Reliable and consistent performance
- User-friendly interface and operation
- Cumplimiento de seguridad and regulatory certification
- Professional technical support and services
- Durable construction for long-term use
- International medical device standards compliance
Cumplimiento normativo y certificaciones internacionales & International Certifications
The Digital Mammography System complies with all international regulatory requirements and holds the following certifications:
- Aprobación de la FDA: Approved by the U.S. Food and Drug Administration (FDA) for commercial distribution and clinical use in the United States
- Marcado CE: 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
Directrices de uso y mejores prácticas & Best Practices
- Capacitación del operador: Requires trained and qualified medical personnel for operation in accordance with regulatory requirements and manufacturer guidelines
- Protocolos de seguridad: Follow all safety protocols and operational guidelines provided in the comprehensive product manual and training materials
- Mantenimiento & Calibration: Regular maintenance and calibration ensure optimal performance, accuracy, and longevity of the device
- Garantía de calidad y estándares de rendimiento: Use in accordance with medical device regulations, quality standards, and institutional protocols
- Soporte profesional: Dedicated technical support team available for assistance, troubleshooting, and training
- Documentación: Maintain proper documentation of usage, maintenance, and service for regulatory compliance and quality assurance
Garantía de calidad y estándares de rendimiento & Performance Standards
The Digital Mammography System undergoes rigorous quality control testing and validation to ensure consistent performance and reliability. Every unit is tested for:
- Rendimiento funcional and accuracy in clinical applications
- Cumplimiento de seguridad and protective features effectiveness
- Durabilidad and long-term reliability under clinical use
- Regulatory compliance verification and certification
- User interface functionality and ease of operation
- Image quality and diagnostic accuracy
Soporte profesional & Services
We provide comprehensive support services to ensure optimal device performance and user satisfaction:
- Soporte técnico: 24/7 technical support and troubleshooting assistance
- Programas de capacitación: Comprehensive training and education programs for operators and clinical staff
- Mantenimiento Services: Preventive maintenance and service plans to ensure optimal performance
- Piezas de repuesto: Genuine replacement parts and accessories for all components
- Asistencia regulatoria: Support with regulatory compliance and documentation requirements
- Consulta clínica: Expert clinical consultation for optimal device utilization
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