Philips Ict CT System

FDA-Cleared Indications

• Computed tomography imaging of the body for diagnostic purposes.
• Acquisition of cross-sectional images to support evaluation of anatomical structures.
• Use in clinical imaging workflows where CT image quality and radiation-dose management are required.

Clinical Applications

• Diagnostic CT imaging of anatomical structures.
• CT evaluation of the chest, abdomen, pelvis, head, and extremities when clinically indicated.
• Imaging before, during, or after selected image-guided procedures, including embolization planning or assessment.
• Vascular and nonvascular anatomical assessment using CT protocols appropriate to the clinical question.

Reported off-label uses

• CT-based procedural navigation or three-dimensional planning beyond the specific indications described in the device labeling.
• Research and investigational imaging protocols that are not part of the cleared clinical workflow.

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 CT system, not an MRI scanner; it uses ionizing radiation and is not considered MRI-safe equipment.
• Radiation dose depends on the body region, scan protocol, patient size, contrast use, and reconstruction settings. Protocols should be optimized for the clinical question.
• Intravenous iodinated contrast may be used for selected examinations and requires assessment of allergy history, kidney function, and other clinical risks.
• Patient weight, positioning, bore dimensions, table limits, and available accessories should be checked before scanning.
• The system requires trained operators, routine quality assurance, preventive maintenance, and compatibility with the facility's imaging and data systems.