NeuroPace RNS-300M

NeuroPace

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) NumberK141368 ↗
Clearance Date7/10/2014
Product CodeGXR
✅No Recalls Found

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

Category

Neuro

Body Region

Responsive Neurostimulation

MRI Conditions

Legacy NeuroPace RNS-300M — MR Unsafe. Use the RNS-320 (next-generation) for any MRI-conditional clearance. Consult neuropace.com for current MRI guidelines: https://www.neuropace.com/providers/rns-system-mri-guidelines/

Clinical Warnings

WARNING: RNS-300 is NOT MRI conditional. MRI is CONTRAINDICATED.

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