Philips Multidiagnost 4

FDA-Cleared Indications

• Use for diagnostic and interventional procedures requiring real-time fluoroscopic X-ray imaging.
• Use with liquid embolization agents when fluoroscopic imaging is needed to guide delivery and assess treatment.
• Use for imaging of internal anatomy during procedures performed with compatible catheters and other interventional devices.

Clinical Applications

• Fluoroscopic guidance during catheter-based diagnostic examinations.
• Image guidance for delivery of liquid embolization agents.
• Real-time visualization of vascular anatomy during interventional procedures.
• Monitoring device position and treatment effect during image-guided procedures.

Reported off-label uses

• Fluoroscopic guidance for gastrointestinal and genitourinary procedures when clinically appropriate.
• Fluoroscopic guidance for orthopedic or pain-management injections.
• General radiographic or fluoroscopic guidance for procedures outside the specific FDA-cleared labeling, based on institutional practice and clinician judgment.

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

• The system uses ionizing radiation; dose optimization, shielding, collimation and fluoroscopy-time monitoring are important.
• Confirm compatibility between the imaging system, procedure table, catheters, guidewires, contrast agents and liquid embolization materials used in the procedure.
• This is an X-ray fluoroscopy system, not an MRI scanner. Patients with implanted devices should be evaluated according to the implant manufacturer's MRI conditions if MRI is being considered separately.
• Use requires trained personnel familiar with fluoroscopic imaging, radiation safety, sterile technique and management of contrast-related complications.
• The system's age, maintenance status, software, image quality and availability of replacement parts should be verified before clinical use.