📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use with the Siremobil Iso-C 3D system to support three-dimensional imaging and navigation during surgical or interventional procedures.
- Provide image guidance for procedures requiring localization and targeting of anatomy.
- Support image-guided tumor ablation procedures when used with the compatible Siremobil Iso-C 3D imaging system.
Clinical Applications
- Three-dimensional imaging and navigation during image-guided surgery.
- Localization and targeting of lesions during tumor ablation.
- Intraoperative visualization of anatomy when two-dimensional fluoroscopy alone is insufficient.
- Procedural planning and navigation using images acquired by the compatible Siremobil Iso-C 3D C-arm.
Practical Considerations
- The interface is intended for use with a compatible Siremobil Iso-C 3D system; compatibility with current hardware and software should be confirmed before a procedure.
- It is an X-ray-based C-arm imaging system, not an MRI device. Radiation exposure, image quality, and patient positioning should be considered during planning.
- The system requires trained personnel who understand three-dimensional image acquisition, registration, navigation, and the limitations of intraoperative imaging.
- Image guidance does not replace clinical judgment, direct visualization when available, pathology, or other imaging needed for diagnosis and treatment planning.
- The record describes a device interface rather than a standalone implant; it does not have a patient-specific implant size or an implanted service life.
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.