Ratational Angiography Option for Philips Multidiagnost 4

FDA-Cleared Indications

• For use with the Philips Multidiagnost 4 system to provide rotational angiographic imaging.
• For imaging procedures involving liquid embolization agents.
• For acquisition and reconstruction of multiple X-ray images to visualize vascular anatomy during an indicated procedure.

Clinical Applications

• Rotational angiographic imaging during procedures that use liquid embolization agents.
• Imaging vascular anatomy to support planning and device or agent placement during an indicated embolization procedure.

Reported off-label uses

• Three-dimensional vascular mapping during selected endovascular procedures, including aneurysm treatment, vascular stenting, and embolization procedures not involving a labeled liquid embolization indication. These applications should be evaluated by the treating team under applicable institutional and regulatory 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 an X-ray-based imaging option, not an MRI device; MRI safety depends on the complete room installation, including all equipment and accessories.
• Compatibility with the Philips Multidiagnost 4 system, image-processing software, table, and angiographic room configuration should be confirmed before use.
• The room must provide adequate clearance for the rotating imaging components and patient positioning.
• Use requires trained personnel who understand rotational image acquisition, reconstruction, radiation protection, and interpretation.
• Patient and procedure suitability should account for radiation exposure, contrast or embolic-agent risks, and the need to remain appropriately positioned during image acquisition.