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arcadis ordic available with options 3d and 3d navigation interface
Siemens Medi Cal Solutions
Summary: The Arcadis Ordic is a medical imaging device used primarily for 3D navigation in surgical procedures. It is utilized by surgeons and radiologists for precise imaging during tumor ablation and other interventions.
FDA Clearance Information
Pathway
510K
Number
K042793 ↗
Decision Date
October 29, 2004
Product Code
OWB
Device Class
Class 2
Evidence
0 studies
The Arcadis Ordic, manufactured by Siemens Medi Cal Solutions, was cleared via the FDA 510(k) pathway on October 29, 2004. It is classified as a Class 2 device under product code OWB.
What It Is
The Arcadis Ordic is a mobile C-arm imaging system that provides high-quality 3D imaging and navigation capabilities. It is designed to assist clinicians in visualizing anatomical structures during surgical procedures, particularly in the context of tumor ablation. The system enhances accuracy and precision by offering real-time imaging, which is crucial for complex interventions.
Clinical Applications
This device is commonly used in interventional radiology and surgical oncology settings. It is particularly beneficial in procedures requiring precise localization and treatment of tumors, such as radiofrequency ablation or cryoablation. Surgeons and interventional radiologists utilize the Arcadis Ordic in hospitals and specialized clinics, primarily for adult patients undergoing minimally invasive procedures.
Indications for Use
The FDA-cleared indications for the Arcadis Ordic focus on its use in imaging and navigation during tumor ablation procedures. It is intended for patients requiring precise imaging to guide therapeutic interventions, particularly in oncology.
Practical Considerations
The Arcadis Ordic is compatible with various surgical instruments and can be integrated into existing surgical workflows. It is important for users to ensure proper calibration and positioning to maximize imaging accuracy. The system's mobility allows for easy transportation between operating rooms.
Frequently Asked Questions
What is Arcadis Ordic used for?
The Arcadis Ordic is used for 3D imaging and navigation during surgical procedures, particularly for tumor ablation.
What specialties typically use this device?
Specialties such as interventional radiology and surgical oncology commonly use the Arcadis Ordic.
What are the FDA-cleared indications?
The device is indicated for imaging and navigation in tumor ablation procedures, aiding in precise treatment delivery.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.