Philips Gyroscan Nt Release 6 Series

FDA-Cleared Indications

• MRI imaging of the body for diagnostic evaluation.
• Imaging of cardiac anatomy and myocardial tissue abnormalities, including fibrosis, infarction, and scar tissue, when performed under the system’s cleared protocols.

Clinical Applications

• Cardiac MRI evaluation of myocardial structure and tissue characteristics.
• Assessment of suspected myocardial fibrosis, infarction, or scar tissue using contrast-enhanced MRI protocols.
• Diagnostic imaging of patients with cardiac structural changes, including changes associated with arterial hypertension.
• General MRI examinations performed according to the system’s cleared labeling and facility protocols.

Reported off-label uses

• MRI evaluation of additional organs and conditions beyond the specific cardiac applications described in the available device summary may be performed according to institutional protocols, but the exact labeling should be confirmed before use.

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

• MRI safety screening is required before every examination, including assessment of implanted devices, metallic foreign bodies, pregnancy, and other contraindications.
• The system uses a strong static magnetic field and radiofrequency energy; ferromagnetic objects and unsafe equipment must not enter the MRI environment.
• Gadolinium-based contrast may be used for selected cardiac examinations. Kidney function, prior contrast reactions, and current safety guidance should be reviewed before administration.
• Patient positioning, cardiac gating, breath-holding, and MRI-compatible monitoring may be needed for cardiac imaging.
• Operation requires trained MRI technologists and interpretation by qualified radiology or cardiology professionals.