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Robotic TMS system classified as a Class II stereotaxic instrument under 21 CFR 882.4560 with product codes SGE and QFF (K261471), having received FDA 510(k) clearance.
Robotic TMS system classified as a Class II stereotaxic instrument under 21 CFR 882.4560 with product codes SGE and QFF (K261471), having received FDA 510(k) clearance.
Platforms, integrations, and language support vary by plan and region. Confirm final requirements with the vendor.
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Compliance claims are normalized from current vendor documentation and independently reviewed by SOTA2.