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3d navigation interface for siremobile iso-c 3d
Siemens Medical Solutions U
Summary: The 3D Navigation Interface for Siremobil Iso-C 3D is a medical imaging device used to enhance precision in surgical procedures, particularly in tumor ablation. It is primarily used by radiologists and surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K022337 ↗
Decision Date
August 13, 2002
Product Code
IZL
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 13, 2002. It is manufactured by Siemens Medical Solutions U and is classified as a Class 2 medical device.
What It Is
The 3D Navigation Interface for Siremobil Iso-C 3D is an advanced imaging system that provides real-time 3D visualization to assist in surgical procedures. It integrates with the Siremobil Iso-C 3D C-arm to offer precise navigation capabilities, enhancing the accuracy of interventions such as tumor ablations. The device uses imaging technology to create detailed anatomical maps, allowing clinicians to target specific areas with high precision.
Clinical Applications
This device is commonly used in interventional radiology and surgical oncology for procedures that require precise localization and targeting, such as tumor ablation. It is particularly beneficial in complex cases where traditional imaging may not provide sufficient detail. The device is used in hospital operating rooms and interventional suites, primarily serving adult patients undergoing minimally invasive procedures.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring precise navigation and imaging, such as tumor ablation. It is designed to assist clinicians in accurately targeting and treating tumors, improving procedural outcomes.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and be familiar with the integration of 3D navigation technology. Proper training in the use of the interface is essential for maximizing its benefits. The device is typically used in conjunction with other imaging modalities for comprehensive procedural planning.
Frequently Asked Questions
What is the 3D Navigation Interface for Siremobil Iso-C 3D used for?
It is used to provide real-time 3D imaging and navigation during surgical procedures, particularly for tumor ablation.
What specialties typically use this device?
Interventional radiologists and surgical oncologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring precise navigation and imaging, such as tumor ablation.
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.