CPX4 Breast Tissue Expander

Mentor (Johnson & Johnson)

MR UnsafeIndexed from FDA records

What this means for you

MR Unsafe — do not bring into the MRI scanner room. This device cannot safely be in the MRI suite. If a scan is essential, your physician will discuss alternatives.

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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

Regulatory Info

510(k) NumberK161176 ↗
Clearance Date5/22/2016
Product CodeLCJ
✅No Recalls Found

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Breast

Body Region

Chest

MRI Conditions

Contains magnetic port (BufferZone self-sealing patch). Magnetic port creates MRI safety risk — torque and tissue damage possible. Confirm port type before scanning.

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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.