Philips CT 3500

FDA-Cleared Indications

• Diagnostic imaging of the body to assist in evaluating medical conditions.
• Acquisition of cross-sectional images for detailed anatomical visualization.
• Use in procedures requiring imaging assessment associated with embolization liquid agents.

Clinical Applications

• Diagnostic CT imaging of relevant body regions when cross-sectional anatomical information is needed.
• Imaging assessment associated with procedures using embolization liquid agents.
• Image reconstruction and review to support clinical evaluation and treatment planning.

Reported off-label uses

• CT angiography for evaluation of blood vessels when performed under an appropriate clinical protocol.
• CT-guided needle placement or biopsy when the scanner and facility are configured for that purpose.
• CT-based treatment planning in oncology and radiation therapy.

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 scanner uses ionizing radiation; protocols should be adjusted to the patient, examination, and clinical question.
• The device is not MRI equipment and is not used for MRI examinations. MRI safety considerations apply to any external equipment brought into the MRI room.
• Patient weight, body size, positioning, and ability to remain still must be assessed against the system specifications and examination protocol.
• Iodinated contrast may be used for some CT examinations, but contrast administration requires assessment of allergy history, kidney function, pregnancy status, and other contraindications.
• The system should be operated by trained personnel according to the manufacturer's instructions and the facility's quality-assurance procedures.