Sdr 3500 Philips Platinum

FDA-Cleared Indications

• Diagnostic ultrasound imaging of internal anatomical structures.
• Evaluation of tissues and organs using reflected ultrasound waves.
• Noninvasive imaging to support the diagnosis and monitoring of disease.

Clinical Applications

• Ultrasound imaging of abdominal and pelvic organs.
• Imaging of superficial soft tissues and masses.
• Ultrasound evaluation of blood vessels when used with an appropriate compatible transducer.
• Obstetric imaging when supported by the applicable system labeling and transducer.
• Cardiac imaging when supported by the applicable system labeling and transducer.

Reported off-label uses

• Ultrasound guidance for bedside procedures such as vascular access.
• Point-of-care assessment of fluid collections or free fluid.

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

• Use only compatible transducers, accessories and software identified by the manufacturer or facility biomedical engineering department.
• Image quality depends on transducer selection, patient factors, operator technique, calibration and preventive maintenance.
• Ultrasound does not use ionizing radiation and is not an MRI device; it should not be placed in the MRI scanner or MRI-controlled area unless specifically approved for that environment.
• Contraindications and precautions depend on the examination, acoustic output, transducer and patient condition; follow the system operator manual and current ultrasound safety guidance.
• The FDA record identifies the device as a Class II device cleared through 510(k) K873937 in 1988 under product code IYO; detailed original specifications should be confirmed from Philips documentation.