ALLOX2

Sientra

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) NumberK214124 ↗
Clearance Date6/7/2023
Product CodeLCJ
✅No Recalls Found

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

Category

Breast Tissue Expanders

Body Region

Chest

MRI Conditions

Dual-port system for fluid drainage and filling. Contains magnetic components — MRI Unsafe. Verify port type before any MRI.

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