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integra radionics imagefusion 3
Integra Radionics
Summary: The Integra Radionics ImageFusion 3 is a medical device used in the integration of imaging data for surgical planning and navigation. It is typically used by surgeons and radiologists in settings requiring precise image-guided interventions.
FDA Clearance Information
Pathway
510K
Number
K063230 ↗
Decision Date
December 21, 2006
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 21, 2006, by Integra Radionics. It is classified as a Class 2 device under the product code MUJ.
What It Is
The Integra Radionics ImageFusion 3 is a sophisticated software tool that integrates multiple imaging modalities, such as CT and MRI, to provide enhanced visualization for surgical planning and navigation. It assists clinicians in accurately localizing and targeting anatomical structures, which is crucial in complex surgical procedures. The device enhances the precision of interventions by allowing for real-time image fusion and navigation.
Clinical Applications
This device is commonly used in neurosurgery, oncology, and other specialties that require precise image-guided interventions. It is particularly valuable in procedures where accurate localization of lesions or anatomical structures is critical, such as tumor resections or biopsies. The device is used in hospital settings, typically in operating rooms or interventional radiology suites, and is beneficial for patient populations requiring complex surgical interventions.
Indications for Use
The FDA-cleared indications for this device involve its use in integrating imaging data to aid in surgical planning and navigation. It is intended for patients who require precise image-guided interventions, such as those undergoing complex surgeries or treatments that benefit from enhanced visualization of anatomical structures.
Practical Considerations
Clinicians should ensure compatibility with existing imaging systems and verify the device's integration capabilities with various imaging modalities. Familiarity with the software interface and navigation techniques is essential for optimal use. The device may require specific training to maximize its benefits in surgical settings.
Frequently Asked Questions
What is Integra Radionics ImageFusion 3 used for?
It is used for integrating imaging data to enhance surgical planning and navigation, particularly in complex procedures requiring precise localization.
What specialties typically use this device?
Specialties such as neurosurgery, oncology, and interventional radiology commonly use this device for image-guided interventions.
What are the FDA-cleared indications?
The device is indicated for use in integrating imaging data to aid in surgical planning and navigation for procedures requiring precise image guidance.
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.