Philips Epiq Diagnostic Ultrasound System Philips Affiniti Diagnostic Ultrasound System

FDA-Cleared Indications

• Diagnostic ultrasound imaging of anatomical structures and physiological processes.
• Cardiac imaging, including evaluation of cardiac anatomy and function.
• Vascular imaging, including assessment of blood flow and vessel structure with Doppler techniques.
• Obstetric and general imaging applications when the appropriate transducer and software are used.

Clinical Applications

• Transthoracic echocardiography for assessment of cardiac chambers, valves, wall motion, and ventricular function.
• Duplex ultrasound evaluation of arteries and veins, including blood-flow assessment with color and spectral Doppler.
• Ultrasound imaging of abdominal, pelvic, superficial, and other soft-tissue structures.
• Obstetric ultrasound examinations, including fetal anatomic and physiologic assessment.
• Ultrasound guidance for selected diagnostic or interventional procedures when the system, transducer, and procedure are appropriately labeled.

Reported off-label uses

• Point-of-care ultrasound applications outside the system's specific cleared examination claims, such as rapid bedside assessment in emergency or critical-care settings.
• Ultrasound-guided vascular access or other bedside procedures when the particular configuration and use are not specifically covered by the applicable labeling.

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 is a console-based platform; imaging capability depends on the connected transducer, software configuration, presets, and clinical application.
• Different transducers are used for different depths and body regions, including cardiac, vascular, abdominal, superficial, endocavitary, and obstetric imaging.
• Ultrasound does not use ionizing radiation and is not an MRI device; the console and transducers should not be taken into the MRI scanner room unless specifically approved for that environment.
• Use requires trained operators, appropriate infection-control processing, and adherence to acoustic-output and thermal-safety principles, including ALARA when imaging pregnancy.
• Contraindications and limitations depend on the examination and transducer. External scanning is generally noninvasive, while endocavitary or procedure-guided examinations require additional precautions.