📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use for integrating and displaying medical imaging data to support surgical planning and navigation.
- Use to assist clinicians in localizing anatomical structures or targets during image-guided procedures.
- Use with compatible imaging data and navigation systems according to the device labeling and clinical workflow.
Clinical Applications
- Image-guided neurosurgical planning and navigation
- Localization of intracranial lesions or other anatomical targets during surgery
- Planning and guidance for procedures such as lesion biopsy or tumor resection when compatible imaging data are available
- Fusion and visualization of imaging studies, such as CT and MRI, for operative guidance
Practical Considerations
- This is software rather than an implanted or disposable device, so physical device size and vascular access requirements do not apply.
- Compatibility must be confirmed with the facility's imaging systems, image formats, navigation hardware, and operating-room or procedure-suite network.
- Image registration and fusion should be checked by the clinical team before relying on the displayed anatomy for navigation.
- MRI safety depends on the connected hardware and the imaging environment; the software itself should not be treated as an MRI-safe device without reviewing the applicable system documentation.
- Use requires trained personnel familiar with image registration, navigation workflows, software limitations, and verification of targeting accuracy.
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.