Philips Integris Allura Flat Detector Release 1 2

FDA-Cleared Indications

• Use as a diagnostic X-ray imaging system for fluoroscopy and angiography.
• Use to provide real-time X-ray imaging during interventional procedures.
• Use for visualization during procedures involving liquid embolization agents, as specified in the applicable labeling.

Clinical Applications

• Fluoroscopic and angiographic imaging during vascular procedures.
• Image guidance for embolization procedures involving liquid embolization agents.
• Visualization of blood vessels during catheter-based interventions.
• Real-time imaging to support device positioning and procedural monitoring.

Reported off-label uses

• Neurovascular angiography and image guidance for selected endovascular procedures may be performed with this type of system, depending on the installed configuration and facility protocols.
• Image guidance for nonvascular fluoroscopic interventions may be possible, but use must follow the system labeling, configuration, and institutional policies.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• This is a fixed fluoroscopy and angiography system, not an implantable device or an MRI scanner.
• Image quality and available applications depend on the installed detector, C-arm configuration, software version, accessories, and facility-specific options.
• The system uses ionizing radiation; radiation dose should be managed with appropriate collimation, exposure settings, shielding, and monitoring.
• Compatible catheters, guidewires, embolic agents, contrast media, and other devices must be selected according to their own labeling and the imaging system's technical specifications.
• Regular preventive maintenance, calibration, quality-control testing, and operator training are required. It is not MRI safe as a complete system and should not be taken into the MRI scanner room unless specifically evaluated and approved for that environment.